Browse Device Recalls
68 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 68 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 68 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| Apr 29, 2021 | HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indica... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 29, 2021 | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated f... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 29, 2021 | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Pr... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 29, 2021 | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Mar 4, 2021 | Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascu... | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... | Class II | Covidien, LP |
| Mar 4, 2021 | Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/... | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... | Class II | Covidien, LP |
| Mar 4, 2021 | Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/T... | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm,... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 -... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Univer... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.