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
Sep 21, 2021 EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unr... Class II Philips Ultrasound Inc
Aug 19, 2021 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100... Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... Class II Philips Ultrasound Inc
Aug 19, 2021 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100... Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... Class II Philips Ultrasound Inc
Aug 6, 2021 EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2... Due to a software defect that can intermittently cause the system to lock-up which exiting Review... Class II Philips Ultrasound Inc
Aug 6, 2021 Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5... Due to a software defect that can intermittently cause the system to lock-up which exiting Review... Class II Philips Ultrasound Inc
Jul 22, 2021 EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7... Ultrasound system control panel arm swivel lock could fail, which could cause the control panel a... Class II Philips Ultrasound Inc
Dec 24, 2020 Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5... Control panel arm assembly could have missing or loose screws where undue force, pressure or weig... Class II Philips Ultrasound Inc
Dec 16, 2020 Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G... The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color F... Class II Philips Ultrasound Inc
Oct 27, 2020 All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, E... The manufacturer has determined that with certain uncommon workflows there is potential for incor... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accesso... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used w... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used w... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Aug 30, 2019 Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used a... The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... Class II Philips Ultrasound Inc
Apr 29, 2019 Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Model... There is a potential that the image of one patient could get unexpectedly moved into another pati... Class II Philips Ultrasound 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.