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Browse Device Recalls

17 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 17 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 17 FDA device recalls.

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DateProductReasonClassFirm
Jul 12, 2024 Aespire View. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 7900. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Amingo. OUS only. Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Avance. This anesthesia gas machine is intended to provide general inhalation... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. Th... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys. This anesthesia gas machine is intended to provide general inhalation ... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys CS2. This anesthesia gas machine is intended to provide general inhalat... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to ... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 100. This anesthesia gas machine is intended to provide general inhal... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Dec 29, 2023 EVair air compressor, model numbers: M1230849 and M1230847 GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... Class I Datex-Ohmeda, Inc.
Dec 29, 2023 EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... Class I Datex-Ohmeda, Inc.
Dec 29, 2023 EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... Class I Datex-Ohmeda, Inc.
Jun 28, 2018 The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARES... The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. Class II Datex-Ohmeda, Inc.
Dec 8, 2017 CARESCAPE R860 ventilators with software version 10SP05 Product Usage: Th... Potential for the display processor to experience an unexpected failure. Class II Datex-Ohmeda, Inc.
Jun 26, 2012 GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... Class I GE Healthcare, LLC

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.