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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
Oct 5, 2018 Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant in... GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are... Class II Ohmeda Medical
Dec 1, 2017 Rotating IV Pole Rotating IV Pole falls under the category classified as... There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a by... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates ... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an i... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a ... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators p... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer-... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmer... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a cont... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is ... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
Nov 18, 2016 Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant... Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord a... Class II Ohmeda Medical
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.