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Cardinal Health 200, LLC
Cardinal Health 200, LLC: 276 FDA recall reports
Every medical device recall the FDA has published for Cardinal Health 200, LLC. The fault, and how the agency graded it.
276Reports
31Class I
151Ongoing
2026-04-08Most recent
31 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Z-1768-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
- Product
- Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 198,900 units
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Se
Z-1203-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
- Product
- Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
- Where it went
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
- How much
- 1,169,726 units
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium
Z-0897-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
- Product
- ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue,...
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 251,165 units
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, R
Z-0208-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and...
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- all lots
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.
Z-0207-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- all lots
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch
Z-0211-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch...
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- all lots
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266
Z-0209-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- all lots
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888
Z-0206-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- all lots
Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Ref
Z-0210-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- all lots
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Sma
Z-1917-2025 · Class II · reported 2025-06-18 · Completed
- Why it was recalled
- Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Product
- SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Where it went
- Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
- How much
- 6517 cases total
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B
Z-1919-2025 · Class II · reported 2025-06-18 · Completed
- Why it was recalled
- Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Product
- Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Where it went
- Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
- How much
- 6517 cases total
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P
Z-1918-2025 · Class II · reported 2025-06-18 · Completed
- Why it was recalled
- Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Product
- Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Where it went
- Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
- How much
- 6517 cases total
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Z-1870-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Product
- Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
- How much
- 370
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Z-1871-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Product
- Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
- How much
- 1710
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Z-1872-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Product
- Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
- How much
- 58742
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Z-1873-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Product
- Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
- How much
- 51378
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Z-1875-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Product
- Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
- How much
- 2280
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Z-1874-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Product
- Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
- How much
- 10438
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPT
Z-1132-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T...
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP
Z-1126-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ19; 17) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ20; 18) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU1; 19) KIT, HEAD AND NECK , Catalog...
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK,
Z-1128-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Z-1131-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTER
Z-1133-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID EN
Z-1129-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog...
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOF
Z-1130-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog...
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION
Z-1135-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK,...
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 793,785 total units
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRAN
Z-1134-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT,...
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,M
Z-1127-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEH
Z-1137-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLO
Z-1136-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Product
- Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLX 10) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLY 11) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLZ
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- How much
- 973,785 total units
Showing the 30 most recent of 276. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls