Cardinal Health: 73 FDA recall reports
Every medical device recall the FDA has published for Cardinal Health. The fault, and how the agency graded it.
73Reports
3Class I
20Ongoing
2022-12-14Most recent
3 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.
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended f
Z-0356-2023 · Class II · reported 2022-12-14 · Ongoing
- Why it was recalled
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Product
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
- Where it went
- Nationwide
- How much
- N/A
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 I
Z-0358-2023 · Class II · reported 2022-12-14 · Ongoing
- Why it was recalled
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Product
- Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
- Where it went
- Nationwide
- How much
- N/A
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drain
Z-0360-2023 · Class II · reported 2022-12-14 · Ongoing
- Why it was recalled
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Product
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
- Where it went
- Nationwide
- How much
- N/A
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bl
Z-0359-2023 · Class II · reported 2022-12-14 · Ongoing
- Why it was recalled
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Product
- Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
- Where it went
- Nationwide
- How much
- N/A
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drain
Z-0361-2023 · Class II · reported 2022-12-14 · Ongoing
- Why it was recalled
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Product
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
- Where it went
- Nationwide
- How much
- N/A
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Int
Z-0357-2023 · Class II · reported 2022-12-14 · Ongoing
- Why it was recalled
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Product
- Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
- Where it went
- Nationwide
- How much
- N/A
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Z-0376-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 270,839 units
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Z-0375-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 364,481 units
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Z-0371-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 363,480 units
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Z-0370-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 231,219 units
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Z-0372-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 17,174 units
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Z-0369-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 169,262 units
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Z-0377-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 9,990 units
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Z-0374-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 29,893 units
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Z-0368-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 224,312 units
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Z-0373-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 146,939 units
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Z-0378-2022 · Class II · reported 2021-12-22 · Ongoing
- Why it was recalled
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Product
- RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
- Where it went
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- How much
- 8,950 units
Class I
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed devic
Z-2286-2021 · Class I · reported 2021-09-01 · Ongoing
- Why it was recalled
- Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Product
- Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
- Where it went
- US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
- How much
- 267,217,860 eaches in total
Class I
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed devi
Z-2285-2021 · Class I · reported 2021-09-01 · Ongoing
- Why it was recalled
- Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Product
- Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
- Where it went
- US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
- How much
- 267,217,860 eaches in total
Class I
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed dev
Z-2284-2021 · Class I · reported 2021-09-01 · Ongoing
- Why it was recalled
- Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Product
- Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
- Where it went
- US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
- How much
- 267,217,860 eaches in total
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Z-1016-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Z-1020-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Z-1012-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Z-1025-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Z-1037-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
Z-1030-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Z-1008-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Z-1014-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Z-1024-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
Z-1033-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Product
- AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
- Where it went
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- How much
- 7,659,634 total units
Showing the 30 most recent of 73. 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.
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