Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2012 | Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate che... | A drafting error during an unrelated design change has led to 4 misleading dimensions on the draw... | Class II | Biomet U.K., Ltd. |
| May 9, 2012 | Brand name: RayStation. Generic name: Treatment Planning System. Software ... | The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, R... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 10, 2012 | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automate... | The action was initiated due power supply failure. During a power supply failure the instrument... | Class II | Vital Scientific N.V. |
| Jan 10, 2012 | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #... | The action was initiated due power supply failure. During a power supply failure the instrument... | Class II | Vital Scientific N.V. |
| Jan 10, 2012 | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automate... | The action was initiated due power supply failure. During a power supply failure the instrument... | Class II | Vital Scientific N.V. |
| Jan 10, 2012 | Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Us... | The action was initiated due power supply failure. During a power supply failure the instrument... | Class II | Vital Scientific N.V. |
| Jan 10, 2012 | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: aut... | The action was initiated due power supply failure. During a power supply failure the instrument... | Class II | Vital Scientific N.V. |
| Jan 5, 2012 | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is inte... | Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant rep... | Class II | Cook Ireland Ltd. |
| Oct 10, 2011 | SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manu... | This notice concerns behavior of the SharePlan that may be unexpected and not clearly described i... | Class II | RAYSEARCH LABORATORIES AB |
| Oct 6, 2011 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS ... | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Nov 1, 2010 | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiograp... | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. | Class II | Canon Inc. |
| Jul 29, 2010 | TD-Synergy. Laboratory Information System. | Technidata has discovered that using the F8 key in the ERM session to add a combined test can res... | Class II | Technidata S.A. |
| 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 |
| Jun 9, 2009 | NDI P7 Position Sensor, Stereotaxic Instrument | Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras)... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Jun 4, 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is u... | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk o... | Class II | Orthosoft, Inc. dba Zimmer CAS |
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.