Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 23, 2011 | Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENT... | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... | Class II | Exactech, Inc. |
| Sep 20, 2011 | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier ... | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve ... | Class II | Metrex Research, LLC. |
| Apr 13, 2011 | IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical... | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. | Class II | Extremity Medical LLC |
| Dec 31, 2010 | ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki... | The impacted product was not intended for commercial distribution to end users. | Class III | Kimberly-Clark Corporation |
| Oct 10, 2010 | . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys F... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 Ver... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Fem... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys F... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Oct 10, 2010 | 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Fem... | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... | Class II | Zimmer, Inc. |
| Feb 17, 2010 | A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible gener... | Customers may be storing objects on the base and/or around the column of the surgical table. Thi... | Class II | Steris Corporation |
| Dec 29, 2009 | Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV53... | In the vast majority of products specified, a shrinkage of the air chamber during sterilization h... | Class II | Spiegelberg Gmbh & Co. KG |
| Nov 17, 2009 | CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for cathet... | The recall was initiated because Biosense Webster has become aware of information regarding a pot... | Class II | Biosense Webster, Inc. |
| Sep 17, 2009 | MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-L... | Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... | Class II | Kimberly-Clark Corporation |
| Sep 17, 2009 | MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, ... | Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... | Class II | Kimberly-Clark Corporation |
| Apr 6, 2009 | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring ... | The firm is initiating this recall because the implied or stated indications in their labeling as... | Class II | Stellate Systems |
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.