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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Oct 1, 2015 ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used... Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the c... Class I Hummingbird Med
Mar 11, 2015 ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and ... Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties. Class I Hummingbird Med
Jul 3, 2013 Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Pai... Lancets were not sterilized within the dose range established by sterilization validation. Class II KooJoo Trading Company

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.