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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Jun 30, 2023 LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC ... Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable cu... Class II Cardiac Assist, Inc
Dec 5, 2022 SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE... A software update (v1.1.5) has been developed to address the issue of Critical Failure which can ... Class I Cardiac Assist, Inc
Jul 21, 2022 TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen ... Class I Cardiac Assist, Inc
Oct 14, 2021 SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... Class III Cardiac Assist, Inc
Mar 19, 2021 Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheteriza... On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. ... Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product:... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product:... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Mar 6, 2020 TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 573... Failure to prime due to an assembly error Class II Cardiac Assist, Inc
Nov 19, 2019 TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product ... The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. Class II Cardiac Assist, 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.