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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 30, 2021 NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. ... (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... Class II Nico Corp.
Apr 30, 2021 Myriad-LX Light Source-for delivery of light to the surgical field to enhance... (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... Class II Nico Corp.
Jun 19, 2018 NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... Mislabeled hook pouch included a transport/storage label rather than the product label containin... Class II Nico Corp.
Jul 29, 2015 NICO Myriad Console Model number NN-7000 The Myriad System is a surgical... Two cables within the console were inadvertently twisted during manufacturing. The individual wir... Class II Nico Corp.
Feb 24, 2014 Myriad handpiece Tissue morcellator This recall has been initiated due to a defective component within the handpiece which will caus... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.

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.