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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
Mar 7, 2023 REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Inten... Error in the Introduction section of the user manual that indicates the device may be used for th... Class II Compass Health Brands (Corporate Office)
Jan 10, 2022 Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLE... Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries,... Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, ... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, M... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Mo... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, ... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, M... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Jun 18, 2018 CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ... A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement ... Class I Compass Health Brands (Corporate Office)

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.