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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Oct 9, 2025 bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imagin... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; Sys... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Sep 4, 2024 bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and b... The internal power connections at the power inlet of the ultrasound devices can come loose result... Class II B-K Medical A/S
Nov 30, 2023 bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. Class II B-K Medical A/S
Jun 28, 2016 BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with softw... In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be un... Class II B-K Medical A/S

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.