Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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Date	Product	Reason	Class	Firm
Nov 10, 2017	MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tub...	Particulate found on the Curlin spike.	Class II	Zevex Incorporated (dba Moog Medical Medical De...
Nov 10, 2017	BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Autom...	BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urin...	Class II	C.R. Bard, Inc.
Nov 10, 2017	MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tub...	Particulate found on the Curlin spike.	Class II	Zevex Incorporated (dba Moog Medical Medical De...
Nov 10, 2017	MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tub...	Particulate found on the Curlin spike.	Class II	Zevex Incorporated (dba Moog Medical Medical De...
Nov 10, 2017	MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tub...	Particulate found on the Curlin spike.	Class II	Zevex Incorporated (dba Moog Medical Medical De...
Nov 10, 2017	NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStag...	Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatme...	Class II	NxStage Medical, Inc.
Nov 10, 2017	Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.	Internal program testing shows that product may not reach the indicated expiration date.	Class II	Wiener Laboratories
Nov 10, 2017	Ingenuity Core, (Code 728321) Intended to produce images of the head and b...	Philips has identified that certain fasteners cannot be confirmed to have been torqued according ...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 10, 2017	MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tub...	Particulate found on the Curlin spike.	Class II	Zevex Incorporated (dba Moog Medical Medical De...
Nov 10, 2017	Brilliance iCT Intended to produce images of the head and body by computer...	Philips has identified that certain fasteners cannot be confirmed to have been torqued according ...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 10, 2017	CritiCore Automated Urine Output and Temperature Monitor	Issues identified with the monitor including urine output measurement errors, temperature measure...	Class II	C.R. Bard, Inc.
Nov 10, 2017	Ingenuity Core 128, (Code 728323) Intended to produce images of the head a...	Philips has identified that certain fasteners cannot be confirmed to have been torqued according ...	Class II	Philips Medical Systems (Cleveland) Inc
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	Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in v...	An increase in the number of failed calibration events or negative bias with Quality Control (QC)...	Class II	Siemens Healthcare Diagnostics, Inc.
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	ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: T...	Certain catheters could have a compromised catheter shaft due to a manufacturing defect which cou...	Class II	Vascular Insights, LLC
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 8, 2017	SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system	There is a potential risk of unnecessary radiation exposure due to a software issue found in the ...	Class II	Siemens Medical Solutions USA, Inc
Nov 8, 2017	Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number ...	Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesi...	Class II	Bard Medical Division
Nov 8, 2017	Philips Healthcare IQon Spectral CT computed tomography x-ray system	There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 8, 2017	Philips Healthcare Brilliance iCT SP computed tomography x-ray system	There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 8, 2017	SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnosti...	There is a potential risk of unnecessary radiation exposure due to a software issue found in the ...	Class II	Siemens Medical Solutions USA, Inc
Nov 8, 2017	Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1...	When an error message remains displayed and is not cleared in the Protura software with the Elekt...	Class II	Med Tec Inc
Nov 8, 2017	SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnosti...	There is a potential risk of unnecessary radiation exposure due to a software issue found in the ...	Class II	Siemens Medical Solutions USA, Inc
Nov 8, 2017	SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic sy...	There is a potential risk of unnecessary radiation exposure due to a software issue found in the ...	Class II	Siemens Medical Solutions USA, Inc
Nov 8, 2017	Philips Healthcare Brilliance iCT computed tomography x-ray system	There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t...	Class II	Philips Medical Systems (Cleveland) Inc
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
Nov 7, 2017	Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To det...	The Broad Quantification option of the Symbia product software version VB20A may not allow modifi...	Class II	Siemens Medical Solutions USA, Inc.
Nov 7, 2017	Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To de...	The Broad Quantification option of the Symbia product software version VB20A may not allow modifi...	Class II	Siemens Medical Solutions USA, Inc.
Nov 6, 2017	Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and ...	Stent possibly unable to be fully released from the delivery system.	Class II	Boston Scientific Corporation
Nov 6, 2017	Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vit...	Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w...	Class III	Beckman Coulter Inc.
Nov 6, 2017	Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be ...	Scalpels lot contains non-sterile products labeled as sterile.	Class II	Southmedic, Inc.
Nov 6, 2017	UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro...	Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w...	Class III	Beckman Coulter Inc.
Nov 6, 2017	Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and...	Stent possibly unable to be fully released from the delivery system.	Class II	Boston Scientific Corporation
Nov 6, 2017	Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used...	Reports of incorrect priming volume due to manufacturing with incorrect tubing.	Class II	CareFusion 303, Inc.
Nov 6, 2017	Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro...	Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp...	Class II	Owen Mumford USA, Inc.
Nov 6, 2017	Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic de...	Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w...	Class III	Beckman Coulter Inc.
Nov 6, 2017	Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro...	Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp...	Class II	Owen Mumford USA, Inc.
Nov 3, 2017	bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (...	The protective shield was retracted, and the blade was exposed.	Class II	Beaver-Visitec International Inc.
Nov 3, 2017	ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 P...	Contact lenses lack sterility assurance.	Class II	Alden Optical

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.