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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
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultras... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Ec... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Ec... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echoca... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Apr 21, 2022 Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS The warning label was printed with the incorrect weight capacity. The correct weight limit is 400... Class II Oakworks Inc
Apr 21, 2022 PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 Product label was printed without the UDI number and warning label was printed with the incorrect... Class II Oakworks Inc
Jun 29, 2021 Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowle... Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the br... Class II Oakworks Inc
May 2, 2019 OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - ... Table assembly error with incorrect actuators for the lateral and longitudinal table movements Class II Oakworks Inc
Jul 31, 2017 Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 3... The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR30... Class II Oakworks 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.