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

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 18, 2014 Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M100 set. Product number 104182. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M100 PRE pump infusion set. Product number 107791. Each set is package... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a pl... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MAR... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex M100. Product number 106697. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma HF1000 preset (new design). Product number 107639. Each set is package... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex M150. Product number 109990. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plasti... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Apr 16, 2014 Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Pr... The firm received several complaints for internal blood leaks involving various lot numbers produ... Class II Gambro Renal Products, Incorporated
Apr 16, 2014 Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Ren... The firm received several complaints for internal blood leaks involving various lot numbers produ... Class II Gambro Renal Products, Incorporated
Dec 9, 2013 Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Nu... Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets. Class II Gambro Renal Products, Incorporated

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.