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Browse Device Recalls

67 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 67 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 67 FDA device recalls.

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DateProductReasonClassFirm
Dec 19, 2022 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... Class I Datascope Corp.
Nov 15, 2021 Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0... Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... Class I Datascope Corp.
Nov 15, 2021 Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0... Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... Class I Datascope Corp.
Sep 21, 2021 Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Card... A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum run... Class I Datascope Corp.
Sep 8, 2021 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7... The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in... Class II Datascope Corp.
Sep 8, 2021 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7... The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b... Class II Datascope Corp.
Sep 8, 2021 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3... The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in... Class II Datascope Corp.
Sep 8, 2021 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3... The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b... Class II Datascope Corp.
Mar 22, 2021 Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 22, 2021 Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Oct 3, 2019 Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave... One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier... Class II Datascope Corp.
Jun 17, 2019 Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope Corp.
Jun 17, 2019 CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova... If battery maintenance is not performed per instructions, the battery may provide less than the m... Class I Datascope Corp.
Jun 17, 2019 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... Battery short-run times and unanticipated stoppage may be due to user not performing battery main... Class I Datascope Corp.
Jun 17, 2019 CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova... If battery maintenance is not performed per instructions, the battery may provide less than the m... Class I Datascope Corp.
Jun 17, 2019 CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope Corp.
Jun 17, 2019 CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope 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.