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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Jul 8, 2021 Zippie Voyage, early intervention stroller - Product Usage: is manually opera... The seating system unexpectedly detached, which resulted in the seating system falling to the gro... Class II Sunrise Medical (US) LLC
Jul 8, 2021 Zippie Voyage, early intervention stroller - Product Usage: is manually opera... The seating system unexpectedly detached, which resulted in the seating system falling to the gro... Class II Sunrise Medical (US) LLC
Feb 13, 2020 Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated power... Due to programming errors in the Controller, an increase in the set motor parameters can be made ... Class II Sunrise Medical (US) LLC
Jul 1, 2016 Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 serie... There is an observed failure of the backrest bracket which can fatigue over the life time of the ... Class II Sunrise Medical (US) LLC
Jul 27, 2015 Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 ... Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... Class II Sunrise Medical (US) LLC
Jul 27, 2015 Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - ... Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... Class II Sunrise Medical (US) LLC
Dec 19, 2014 Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. There is the potential for the height adjustable handle to dislodge due to failing locking mechan... Class II Sunrise Medical (US) LLC
Dec 19, 2014 Quickie Q7 Adult Rigid Wheelchair Model EIR4. There is the potential for the height adjustable handle to dislodge due to failing locking mechan... Class II Sunrise Medical (US) LLC
Nov 11, 2013 Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (... There is a remote possibility for the plastic latch to deform over the lifetime of use. When thi... Class II Sunrise Medical (US) LLC
Jun 26, 2012 Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quicki... Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual... Class II Sunrise Medical (US) LLC

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.