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 |
|---|---|---|---|---|
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Mar 26, 2024 | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N | Complaints have been received with allegations of Incorrect Needle Curvature. | Class II | SURGICAL SPECIALTIES |
| Mar 7, 2024 | POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Par... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Par... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| Sep 24, 2016 | BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provid... | Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential ... | Class II | Surgical Specialties Mexico S DE RL DE CV |
| May 20, 2016 | Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N | Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP becau... | Class II | SSC- Surgical Specialties Corporation |
| Aug 15, 2012 | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... | Potential for bent tips. | Class II | Surgical Specialties Puerto Rico Inc. dba Angio... |
| Aug 15, 2012 | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... | Potential for bent tips. | Class II | Surgical Specialties Puerto Rico Inc. dba Angio... |
| Aug 15, 2012 | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... | Potential for bent tips. | Class II | Surgical Specialties Puerto Rico Inc. dba Angio... |
| Aug 15, 2012 | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... | Potential for bent tips. | Class II | Surgical Specialties Puerto Rico Inc. dba Angio... |
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.