Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 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 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2024 | Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 | Due to a classification error in our inventory management system, these medical devices were ship... | Class II | Cypress Medical Products LLC |
| Aug 20, 2024 | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 | Due to a classification error in our inventory management system, these medical devices were ship... | Class II | Cypress Medical Products LLC |
| Aug 6, 2024 | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog ... | The syringes that were inadvertently shipped from the Distribution Center. This product was on qu... | Class II | Cypress Medical Products LLC |
| Jul 24, 2024 | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. ... | Affected syringes lack FDA clearance. | Class II | Cypress Medical Products LLC |
| Aug 11, 2021 | McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Par... | Manufacturer issued a recall due to an EO indicator color. The indicator should change from red t... | Class II | Cypress Medical Products LLC |
| Feb 27, 2019 | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numb... | Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA... | Class III | Cypress Medical Products LLC |
| Sep 4, 2018 | McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P P... | Small hole at the end of the syringe is impeding suction of liquid. | Class II | Cypress Medical Products LLC |
| Jul 2, 2018 | Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Me... | The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of produ... | Class II | Cypress Medical Products LLC |
| Nov 17, 2017 | 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Sta... | Product not meeting the iodine assay level requirements to support 36 month expiration dating. | Class II | Cypress Medical Products LLC |
| Apr 15, 2013 | Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; sing... | Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbili... | Class II | Cypress Medical Products 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.