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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
May 2, 2023 Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spif... Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator... Class II Helena Laboratories, Corp.
Apr 6, 2022 V8 Immunodisplacement Kit REF 1803 Due to microbial growth causing interference with interpretation. Class II Helena Laboratories, Corp.
Jan 5, 2021 Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascad... Intermittent potential for shorter than expected clot times. Class II Helena Laboratories, Corp.
Nov 9, 2020 K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATE... Due to complaints received associated with cracked/split test tube caps. Class II Helena Laboratories, Corp.
Aug 8, 2018 ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic ... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Aug 8, 2018 ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic U... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
May 23, 2018 Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... Through an investigation, it has been determined that vials of Collagen packaged within the Colla... Class III Helena Laboratories, Corp.
May 23, 2018 Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... Through an investigation, it has been determined that vials of Collagen packaged within the Colla... Class III Helena Laboratories, Corp.
Feb 27, 2018 SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a... Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended... Class III Helena Laboratories, Corp.
Dec 7, 2017 Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on... Some of the cards show occasional shorter clot times than the expected variation resulting in a p... Class II Helena Laboratories, Corp.
Jul 21, 2017 SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th... The plates do not have wells punched for the controls in the patient 1 area. Class II Helena Laboratories, 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.