Browse Device Recalls
47 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 47 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 47 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 25, 2023 | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 ... | Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequen... | Class II | Riverpoint Medical, LLC |
| Dec 9, 2020 | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 9... | Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile st... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-3... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Aug 3, 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" ... | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... | Class II | Riverpoint Medical, LLC |
| Feb 8, 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The ... | The integrity of the sterile grid packaging is potentially compromised. | Class II | Riverpoint Medical, LLC |
| Jan 9, 2018 | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Us... | Product is labeled with "CE", but is not yet approved in the European Union. | Class III | Riverpoint Medical, LLC |
| Aug 5, 2016 | Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile... | Polypropylene Surgical Sutures are recalled because the seals may become open during distribution... | Class II | Riverpoint Medical, LLC |
| Aug 5, 2016 | Nylon Surgical Suture for human use and vet use, sold under brand name Riverl... | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subs... | Class II | Riverpoint Medical, LLC |
| Dec 13, 2012 | Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "C... | Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the sutu... | Class II | Riverpoint Medical, LLC |
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.