Covidien LLC: 340 FDA recall reports
Every medical device recall the FDA has published for Covidien LLC. The fault, and how the agency graded it.
340Reports
32Class I
55Ongoing
2026-07-08Most recent
32 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.
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that in
Z-2653-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
- Product
- Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.
- Where it went
- U.S. Nationwide distribution including in the states and territories 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, PR, RI SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Virgin Islands. The countries of Albania, Andorra, Argentina, Australia, Austria, Belgium, Bhutan, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guyana, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lithuania, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Togo, Trinidad And Tobago, Turkey, Uganda, United Arab Emirates, Uruguay.
- How much
- 293,659 devices
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Z-2273-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Temperature probe devices lack FDA clearance.
- Product
- Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
- Where it went
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
- How much
- 128,900 units
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devic
Z-2261-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Due to customer complaint regarding incorrect display box labeling.
- Product
- COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
- Where it went
- Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
- How much
- 1,002
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
Z-2272-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Temperature probe devices lack FDA clearance.
- Product
- Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
- Where it went
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
- How much
- 1775 units
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Z-2271-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Temperature probe devices lack FDA clearance.
- Product
- Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
- Where it went
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
- How much
- 23,000 units
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VIT
Z-1557-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
- Product
- HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
- Where it went
- Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.
- How much
- 78 systems
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Z-2038-2024 · Class II · reported 2024-06-19 · Ongoing
- Why it was recalled
- Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
- Product
- EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
- Where it went
- Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.
- How much
- N/A
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: C
Z-2282-2023 · Class II · reported 2023-08-09 · Ongoing
- Why it was recalled
- Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.
- Product
- Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
- Where it went
- Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
- How much
- 6902
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Z-2008-2023 · Class II · reported 2023-07-05 · Ongoing
- Why it was recalled
- Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.
- Product
- Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- Where it went
- International distribution in the country of Taiwan.
- How much
- 1 unit
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Z-0955-2023 · Class II · reported 2023-01-18 · Ongoing
- Why it was recalled
- The product is labeled with the incorrect expiration date.
- Product
- COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
- Where it went
- Foreign Distribution: Hong Kong
- How much
- 21 units
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Z-1775-2022 · Class II · reported 2022-09-28 · Ongoing
- Why it was recalled
- Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
- Product
- Puritan Bennett 560 Ventilator, PB560, CFN 4096600
- Where it went
- Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
- How much
- 5 US
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine t
Z-1467-2022 · Class II · reported 2022-08-03 · Ongoing
- Why it was recalled
- Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
- Product
- TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
- Where it went
- AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
- How much
- 33 units
Class I
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic
Z-1312-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 213,589 units
Class I
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, a
Z-1315-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 25,765 units
Class I
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, an
Z-1317-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 26,474 units
Class I
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, a
Z-1318-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 2,462 units
Class I
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis
Z-1320-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 132,443 units
Class I
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialy
Z-1316-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 576,018 units
Class I
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chron
Z-1313-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 26,675 units
Class I
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chro
Z-1314-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 2,462 units
Class I
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis,
Z-1319-2022 · Class I · reported 2022-07-13 · Ongoing
- Why it was recalled
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Product
- Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, 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, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa,...
- How much
- 13,526 units
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm
Z-0557-2022 · Class II · reported 2022-02-09 · Ongoing
- Why it was recalled
- The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
- Product
- Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
- Where it went
- Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
- How much
- 1,994 devices
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Z-0495-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
- Product
- LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
- Where it went
- Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
- How much
- 504 devices
Class I
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Z-0351-2022 · Class I · reported 2021-12-15 · Terminated
- Why it was recalled
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Product
- Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 278 total
Class I
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Z-0343-2022 · Class I · reported 2021-12-15 · Terminated
- Why it was recalled
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Product
- Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 278 total
Class I
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Z-0342-2022 · Class I · reported 2021-12-15 · Terminated
- Why it was recalled
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Product
- Puritan Bennett 980 Series Ventilator, 980U1ENASAA
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 278 total
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide inf
Z-0332-2022 · Class II · reported 2021-12-15 · Ongoing
- Why it was recalled
- Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
- Product
- Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
- Where it went
- Brazil
- How much
- 2 units OUS
Class I
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Z-0352-2022 · Class I · reported 2021-12-15 · Terminated
- Why it was recalled
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Product
- Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 278 total
Class I
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Z-0348-2022 · Class I · reported 2021-12-15 · Terminated
- Why it was recalled
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Product
- Puritan Bennett 980 Series Ventilator, 980X1ENNISB
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 278 total
Class I
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Z-0341-2022 · Class I · reported 2021-12-15 · Terminated
- Why it was recalled
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Product
- Puritan Bennett 980 Series Ventilator, 980S3ENDICU
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 278 total
Showing the 30 most recent of 340. 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