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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Jun 14, 2016 T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged i... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 5... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches p... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. P... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, wit... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Fre... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... Class II WalkMed Infusion, LLC
Jun 14, 2016 T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... Class II WalkMed Infusion, LLC
Jun 14, 2016 T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 po... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Oct 1, 2015 Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000... The device might fail to detect air in line while infusing the medication Venofer. This may occu... Class II WalkMed Infusion, LLC
Feb 17, 2014 Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton... WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due t... Class II WalkMed Infusion, LLC

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.