Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, In...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Conformis, Inc.
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Medical Devices·1 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Aso, Llc
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x...
Medical Devices·218 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Jarvik Heart Inc
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable,...
Medical Devices·274 affected·Oct 15, 2018
High RiskFDA
Smiths Medical Asd Inc.
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000...
Medical Devices·20,884 affected·Oct 15, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Dev...
Medical Devices·323 affected·Oct 12, 2018
High RiskFDA
Stanley Security Solutions Inc
M200 Fall Monitoring System
Medical Devices·1,101 affected·Oct 11, 2018
High RiskFDA
Baxter Healthcare Corporation
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Medical Devices·8,640 affected·Oct 10, 2018
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Medical Devices·3 affected·Oct 10, 2018
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Medical Devices·4,752 affected·Oct 9, 2018
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Medical Devices·92,225 affected·Oct 9, 2018
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Medical Devices·22,320 affected·Oct 9, 2018
High RiskFDA
Theragenics Corporation
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic n...
Medical Devices·480 affected·Oct 9, 2018
CriticalFDA
Synaptive Medical Inc
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-...
Medical Devices·37 affected·Oct 9, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Medical Devices·20,030 affected·Oct 8, 2018
RecallFDA
Tosoh Bioscience Inc
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for...
Medical Devices·1,000 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Medical Devices·25,640 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Medical Devices·27,250 affected·Oct 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Medical Devices·264 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Medical Devices·1,760 affected·Oct 5, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long n...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·38 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·2 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long n...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·8 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and l...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and lo...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·19 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·3 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·5 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·26 affected·Oct 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and l...
Medical Devices·2,163 affected·Oct 2, 2018
High RiskFDA
Pfizer Inc.
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of min...
Medical Devices·293,880 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·8 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·5 affected·Oct 2, 2018
High RiskFDA
Arrow International Inc
AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Medical Devices·1 affected·Oct 2, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink Encore 29901 Programmer
Medical Devices·4,072 affected·Oct 2, 2018
High RiskFDA
Pfizer Inc.
Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary re...
Medical Devices·119,232 affected·Oct 2, 2018
High RiskFDA
Svs Llc
PremierPro Aluminum Adjustable Walker
Medical Devices·256 affected·Oct 1, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
C3 Wave App, v. 2.0.5
Medical Devices·24 affected·Oct 1, 2018
High RiskFDA
Comet Technologies Usa Inc
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Medical Devices·93 affected·Oct 1, 2018
High RiskFDA
Comet Technologies Usa Inc
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Medical Devices·77 affected·Oct 1, 2018
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Medical Devices·46 affected·Oct 1, 2018