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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Jul 29, 2021 HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook mode... Class II Mizuho OSI
Feb 8, 2021 Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 conta... There is a potential that hand control units may cause the tabletop to slide in the opposite dire... Class II Mizuho OSI
Oct 14, 2019 Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Labe... Due to the potential for fluid ingress into the Arm which could affect the device's electrical sy... Class II Mizuho OSI
Mar 28, 2017 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frame... Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construc... Class II Mizuho OSI
Dec 14, 2015 Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; ... Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assem... Class II Mizuho OSI
Dec 17, 2012 Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table S... Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may mig... Class II Mizuho OSI

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.