Browse Device Recalls
18 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 18 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 18 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surge... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general su... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general ... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surger... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery d... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surg... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general s... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
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.