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Browse Device Recalls

161 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 161 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 161 FDA device recalls.

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DateProductReasonClassFirm
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
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
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
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
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
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
Dec 4, 2018 Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t... Class III Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-1... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal pr... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal prot... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal pro... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protec... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-1... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protecti... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. ... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)45465400394... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Pre... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)761325250... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)76132... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UD... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: ... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 060... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Oct 16, 2017 The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... Class II Stryker Instruments Div. of Stryker Corporation
Mar 10, 2017 Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a ... Product shipped proximate to or past the expiration date listed on the product label. Class II Stryker Instruments Div. of Stryker Corporation
Feb 28, 2017 Stryker SmartLife Large Aseptic Housing (7126-120-000) Stryker Instruments issued a notice of correction for an update to cleaning practices for the Str... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryk... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minim... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryk... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MI... Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ... Class II Stryker Instruments Div. of Stryker Corporation
Oct 11, 2016 RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged ... Class III Stryker Instruments Div. of Stryker Corporation
Aug 17, 2016 Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: ... Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potentia... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2016 120 V Neptune 3 Rover, Model Number: 0703-001-000 Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potent... Class II Stryker Instruments Div. of 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.