Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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Date	Product	Reason	Class	Firm
Oct 11, 2018	M200 Fall Monitoring System	Damaged capacitor on the printed circuit board.	Class II	Stanley Security Solutions Inc
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 10, 2018	Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage:...	Automated external defibrillators may not fully meet IPx5 water ingress specification. The device...	Class II	Philips Electronics North America Corp.
Oct 10, 2018	IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - ...	A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affec...	Class II	Philips Electronics North America Corporation
Oct 10, 2018	Comprehensive Mini Stem, Item No. 113631:	Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S...	Class II	Zimmer Biomet, Inc.
Oct 10, 2018	Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394	Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S...	Class II	Zimmer Biomet, Inc.
Oct 10, 2018	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f...	Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of...	Class II	Baxter Healthcare Corporation
Oct 9, 2018	BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2...	This recall has been initiated due to a software defect found in the Guide System software when u...	Class I	Synaptive Medical Inc
Oct 9, 2018	Theragenics Applicator Needle (18g x 20cm) The device is comprised four ba...	Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed	Class II	Theragenics Corporation
Oct 9, 2018	Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog ...	Discolored powder has confirmed the presence of a foreign substance	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Oct 9, 2018	Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Num...	Discolored powder has confirmed the presence of a foreign substance	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Oct 9, 2018	Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Num...	Discolored powder has confirmed the presence of a foreign substance	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Oct 8, 2018	VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to ...	VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results	Class II	Ortho-Clinical Diagnostics
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	bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134	Some eluates become colored because of remaining hemoglobin in the eluate.	Class II	bioMerieux, Inc.
Oct 8, 2018	Insulia Diabetes Management Companion	The firm identified an issue with the basal calculator identified on the Android version of the I...	Class II	Voluntis
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
Oct 5, 2018	AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Produ...	Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotati...	Class II	Tosoh Bioscience Inc
Oct 5, 2018	AIA-900 Analyzer, Product code 022930, 022930R	Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor o...	Class II	Tosoh Bioscience Inc
Oct 5, 2018	Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u...	Potential for leakage due to defect in the thermoset check valve component.	Class II	ICU Medical, Inc.
Oct 5, 2018	EVO Excel, Emission Computed Tomographic System, Material Number 10910501	The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l...	Class II	Siemens Medical Solutions USA, Inc.
Oct 5, 2018	Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per...	Potential for leakage due to defect in the thermoset check valve component.	Class II	ICU Medical, Inc.
Oct 5, 2018	Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Prod...	The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failur...	Class II	Covidien LLC
Oct 5, 2018	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant in...	GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are...	Class II	Ohmeda Medical
Oct 5, 2018	Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u...	Potential for leakage due to defect in the thermoset check valve component.	Class II	ICU Medical, Inc.
Oct 5, 2018	GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066...	The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ...	Class I	GE Healthcare, LLC
Oct 5, 2018	Hemoglobin A1c Control, Part no. 220232 for use as quality control material t...	Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the...	Class III	Tosoh Bioscience Inc
Oct 3, 2018	Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258...	Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe...	Class II	Medtronic Inc.
Oct 3, 2018	SIGNA Architect system Product Usage: The Signa Architect system is a who...	A small area on the bore surface, which is normally accessible to the patient, can get warm enoug...	Class II	GE Medical Systems, LLC
Oct 2, 2018	Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are...	Laser engraved label does not match with the item in the package	Class II	Straumann Manufacturing, Inc.
Oct 2, 2018	AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable ...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow Au...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	Liquid Cardiac Control, CQ5051	Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 o...	Class II	Randox Laboratories Ltd.
Oct 2, 2018	Liquid Cardiac Control, CQ5052	Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 o...	Class II	Randox Laboratories Ltd.
Oct 2, 2018	Medtronic CareLink 2090 Programmer	Vulnerabilities have been identified in the SDN download process that may allow an individual wit...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 2, 2018	AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow A...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Aff...	The set screw is not able to advance or reverse from the original position in the nail.	Class II	Zimmer Biomet, Inc.
Oct 2, 2018	Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 ...	The firm received complaints of the wrap coming apart and leaking granular material	Class II	Pfizer Inc.
Oct 2, 2018	Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Aff...	The set screw is not able to advance or reverse from the original position in the nail.	Class II	Zimmer Biomet, Inc.
Oct 2, 2018	AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow Aut...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Aff...	The set screw is not able to advance or reverse from the original position in the nail.	Class II	Zimmer Biomet, Inc.
Oct 2, 2018	Liquid Cardiac Control, CQ5053	Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 o...	Class II	Randox Laboratories Ltd.
Oct 2, 2018	Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 05733013...	The firm received complaints of the wrap coming apart and leaking granular material	Class II	Pfizer Inc.
Oct 2, 2018	Medtronic CareLink Encore 29901 Programmer	Vulnerabilities have been identified in the SDN download process that may allow an individual wit...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 2, 2018	AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow A...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Di...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc
Oct 2, 2018	Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Produ...	The firm received complaints of the wrap coming apart and leaking granular material	Class II	Pfizer Inc.
Oct 2, 2018	Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 Th...	The set screw is not able to advance or reverse from the original position in the nail.	Class II	Zimmer Biomet, Inc.
Oct 2, 2018	AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow Aut...	Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i...	Class II	Arrow International Inc

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.