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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.

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DateProductReasonClassFirm
Aug 24, 2018 Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vi... Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
May 10, 2018 Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numb... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 119... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and c... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, 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.