Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 26, 2013 Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option,... Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Op... Class II Varian Medical Systems, Inc. Oncology Systems
Jan 28, 2013 Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48.... The calculation of dose dynamic plans containing different energy fields is incorrect when the Pe... Class II Varian Medical Systems, Inc. Oncology Systems
Nov 5, 2012 Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiat... Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiat... Class II Varian Medical Systems, Inc. Oncology Systems
Sep 24, 2012 ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. T... An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 17, 2012 Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.... Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned H... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 14, 2012 Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model ... Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can c... Class II Varian Medical Systems, Inc. Oncology Systems
Jul 2, 2012 Varian brand Varian ARIA Oncology Information System, Import Export applicat... A software anomaly has been identified with the Import Export Application version 11.0 where MLC... Class II Varian Medical Systems, Inc. Oncology Systems
Jun 18, 2012 Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model... Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments... Class II Varian Medical Systems, Inc. Oncology Systems
May 31, 2011 Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment Syst... Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in ... Class II Varian Medical Systems, Inc. Oncology 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.