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

113 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 113 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 113 FDA device recalls.

Clear
DateProductReasonClassFirm
May 29, 2015 Radiation Therapy Treatment Planning System software RayStation is a softw... An error caused by a floating point precision problem tends to cause a problem with the display o... Class II RAYSEARCH LABORATORIES AB
May 27, 2015 RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Br... Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction dista... Class II RAYSEARCH LABORATORIES AB
May 8, 2015 RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment P... RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VM... Class II RAYSEARCH LABORATORIES AB
Mar 4, 2015 RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, Ra... An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is ... Class II RAYSEARCH LABORATORIES AB
Apr 25, 2014 RayStation software version 4.0.3.4 RayStation is a software system design... This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT h... Class II RAYSEARCH LABORATORIES AB
Feb 14, 2014 RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alon... RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software d... Class II RAYSEARCH LABORATORIES AB
Feb 6, 2014 RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 ... Potential for dose errors due to software program errors. Class II RAYSEARCH LABORATORIES AB
Feb 6, 2014 RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alo... RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calcu... Class II RAYSEARCH LABORATORIES AB
Oct 23, 2013 Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3... Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in R... Class II RAYSEARCH LABORATORIES AB
Feb 15, 2013 RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0... Under some circumstances, imported CT, MR and PET images are offset from their true positions by ... Class II RAYSEARCH LABORATORIES AB
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
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
May 30, 2011 The product affected by this notice is sold under the trade name TomoTherapy... This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Off... Class II RAYSEARCH LABORATORIES AB

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.