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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 27, 2024 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5... Due to connector within the circuit flex extender not meeting specifications resulting in a low c... Class II Westmed, Inc.
Nov 11, 2020 Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX ... There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... Class II Westmed, Inc.
Nov 11, 2020 REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Fem... There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... Class II Westmed, Inc.
Nov 11, 2020 REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing... There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... Class II Westmed, Inc.
Nov 11, 2020 REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 1... There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... Class II Westmed, Inc.
Nov 11, 2020 REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect w... There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... Class II Westmed, Inc.
Nov 11, 2020 REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigta... There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... Class II Westmed, Inc.
Jan 15, 2019 Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for... A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID con... Class II Westmed, Inc.
Jan 15, 2019 Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible I... A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID con... Class II Westmed, Inc.
Jan 15, 2019 Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for u... A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID con... Class II Westmed, Inc.

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.