Browse Device Recalls
2,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,057 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 2,057 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2011 | Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blo... | Stryker Spine has received six reports regarding the breakage of one or more prongs at the extrem... | Class II | Stryker Spine |
| Jan 11, 2011 | Video Naso pharyngo Laryngoscopes | This field action serves to retrospectively document the actions that were taken by Pentax to co... | Class II | Pentax of America Inc |
| Jan 11, 2011 | Video Bronchoscope | This field action serves to retrospectively document the actions that were taken by Pentax to co... | Class II | Pentax of America Inc |
| Jan 11, 2011 | Video Cytoscopes | This field action serves to retrospectively document the actions that were taken by Pentax to co... | Class II | Pentax of America Inc |
| Jan 1, 2011 | I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 ... | i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when... | Class II | Abbott Point Of Care Inc. |
| Aug 11, 2010 | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. ... | There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailab... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Jul 1, 2005 | Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) heari... | Siemens became aware of an issue where an infant or child could open the tamper resistant battery... | Class II | Siemens Hearing Instruments, Inc |
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.