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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Date	Product	Reason	Class	Firm
Mar 7, 2019	Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO ...	The heated tube sets were consistently leaking and detaching from the cassette.	Class II	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
Nov 20, 2018	Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000	The power load floor plates which hold the ambulance cot anchors in place during patient transpor...	Class II	Stryker Medical Division of Stryker Corporation
Oct 10, 2018	Naera Hospital Bassinet, Model No. 4402	It was identified that the volume of air inside the mattress may expand in regions of high altitu...	Class II	Stryker Medical Division of Stryker Corporation
Oct 8, 2018	The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option	The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T...	Class II	Stryker Medical Division of Stryker Corporation
Oct 8, 2018	The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option	The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T...	Class II	Stryker Medical Division of Stryker Corporation
Sep 6, 2018	Altrix¿ Precision Temperature Management System Model: 8001Product Usage: T...	Users may experience alarm fatigue due to frequent alarming relating to patient temperature devia...	Class II	Stryker Medical Division of Stryker Corporation
Aug 13, 2018	IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The Is...	Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.	Class II	Stryker Medical Division of Stryker Corporation
Mar 12, 2018	Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 076...	The power load floor plates which hold the ambulance cot anchors in place during patient transpor...	Class II	Stryker Medical Division of Stryker Corporation
Mar 9, 2018	6376 M-1 Cot Fastener, catalog no. 6376000000	The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i...	Class II	Stryker Medical Division of Stryker Corporation
Mar 9, 2018	6381 M-1 Cot Fastener, catalog no. 6381000000	The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i...	Class II	Stryker Medical Division 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
Jan 25, 2018	CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ...	The recalled products were shipped without the required temperature control packaging, therefore ...	Class II	Stryker Corporation
Dec 21, 2017	3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per bo...	Inadvertent shipment of expired units.	Class II	Stryker Corporation
Nov 17, 2017	StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ...	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 17, 2017	ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 17, 2017	STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin...	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	Stryker Corporation
Nov 17, 2017	STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod...	Routine bioburden testing of certain lots were found to have levels higher than internal acceptab...	Class II	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
Nov 7, 2017	T/Pump temperature therapy pump, Models TP700 and TP700C	The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence,...	Class III	Stryker Medical Division 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
Jul 21, 2017	MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-P...	It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity...	Class II	Stryker Medical Division of Stryker Corporation
Mar 29, 2017	Medi-Therm Hyper/Hypothermia System, MTA7900	The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to...	Class II	Stryker Medical Division 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

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.