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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
Dec 18, 2018 Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga ... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical i... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical inst... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instr... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product ... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, 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.