Browse Device Recalls

353 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 353 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 353 FDA device recalls.

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DateProductReasonClassFirm
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Feb 1, 2023 Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from ... Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and fo... Class II Stryker Medical Division of Stryker Corporation
Jan 25, 2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Nov 11, 2022 Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (Intern... Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury ... Class II Stryker Medical Division of Stryker Corporation
Jun 15, 2022 SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge t... Class II Stryker Instruments Div. of Stryker Corporation
Jan 14, 2022 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general l... A software defect in the camera control unit (CCU) will cause the image on the monitor to flip up... Class II Stryker Corporation
May 12, 2021 Prime TC-transport chair intended for medical purposes to assist a person in... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Isolibrium Support Surface - support surface assists in the prevention and tr... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 TruRize Clinical Chair - support structure that places human occupants in upr... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four buil... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Surgistool-intended to support a healthcare professional during surgical proc... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 IsoGel Air - support surface assists in the prevention and treatment of all p... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Symmetry Plus Treatment Recliner - general hospital use as a convenient seati... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 ComfortGel - assists in the prevention and treatment of all pressure injury s... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Stretcher Chair-for use in all acute care hospitals and medical outpatient se... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 CUB Pediatric Crib- intended to provide a pediatric patient support surface f... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Transport Stretcher 747 - a non-powered, wheeled device designed to support p... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 S3 MedSurg Bed - intended to support and transport patients within the Med/Su... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 InTouch 2131-intended to support a human patient in an acute care setting, M... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Michael Graves with Stryker Highback Chair-intended for pediatric and adult p... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 S3 MedSurg Bed - intended to support and transport patients within the Med/Su... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Proform- support surface is used to assist in the prevention and treatment of... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and sh... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
Feb 26, 2021 Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, M... Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or u... Class II Stryker Corporation
Oct 16, 2020 Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, si... Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to... Class II Stryker Instruments Div. of Stryker Corporation
Aug 12, 2020 Stryker IsoAir 2.0 support surface-provides pressure redistribution and is in... Connector between support surface and pump may be out of tolerance resulting in difficulty in rem... Class II Stryker Medical Division of Stryker Corporation
Apr 7, 2020 Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product... Ambulance Cots may not meet crash test standard BS EN 1789 Class II Stryker Medical Division of Stryker Corporation
Mar 26, 2020 Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Us... Due to a distribution error, product from the affected lot was shipped expired. Class II Stryker Instruments Div. of Stryker Corporation
Jan 22, 2020 Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product ... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bo... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The pr... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 7, 2020 Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Dr... Sterile drapes packaged in an unsealed pouch. Class II Stryker Corporation
Jan 7, 2020 Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. ... Sterile drapes packaged in an unsealed pouch. Class II Stryker Corporation
Nov 6, 2019 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class II Stryker Instruments Div. of Stryker Corporation
Nov 6, 2019 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class II Stryker Instruments Div. of Stryker Corporation
Sep 12, 2019 Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replaceme... Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le... Class II Stryker Corporation
Sep 12, 2019 Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replaceme... Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le... Class II Stryker Corporation
Jul 31, 2019 C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usag... Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... Class II Stryker Instruments Div. of Stryker Corporation
Jul 31, 2019 C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usag... Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... Class II Stryker Instruments Div. of Stryker Corporation
Jul 19, 2019 Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910... Complaints have been received regarding difficulty in removing the driver from the screw. High d... Class II Stryker Corporation
Jul 19, 2019 Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-47... Complaints have been received regarding difficulty in removing the driver from the screw. High d... Class II Stryker Corporation
Apr 23, 2019 Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufa... There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not at... Class II Stryker Corporation
Mar 19, 2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... During manufacture, packaging materials for a small portion of the lot may not have been properly... Class II Stryker Instruments Div. of Stryker Corporation
Mar 7, 2019 Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-6... The heated tube sets were consistently leaking and detaching from the cassette. Class II Stryker Corporation
Mar 7, 2019 Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-04... The heated tube sets were consistently leaking and detaching from the cassette. Class II Stryker Corporation

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.