Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Family Dollar Stores, Llc.
POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
Medical Devices·65 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
Medical Devices·901,260 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
CURAD FIRST AID KIT, SKU 999037
Medical Devices·771 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
Medical Devices·9 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
Medical Devices·99 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265
Medical Devices·5 affected·Jun 23, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Numbe...
Medical Devices·24 affected·Jun 21, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Merlin 2 PCS MER37000 programmer Model MER3400 software
Medical Devices·622 affected·Jun 17, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Merlin PCS 3650 programmer Model 3330 software
Medical Devices·29,996 affected·Jun 17, 2022
High RiskFDA
Luminex Corporation
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Medical Devices·5,601 affected·Jun 17, 2022
High RiskFDA
St. Jude Medical, Cardiac Rhythm Management Division
Merlin.net model MN5000 Software
Medical Devices·0 affected·Jun 17, 2022
High RiskFDA
Luminex Corporation
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Medical Devices·296 affected·Jun 17, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Medical Devices·277 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various Angiography packs/trays
Medical Devices·57 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Breast Abdominoplasty Pack
Medical Devices·1 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various C-section packs
Medical Devices·24 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various convenience packs
Medical Devices·116 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various convenience packs
Medical Devices·118 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
D&C pack
Medical Devices·1 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various Port Insertion Packs
Medical Devices·2 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various ob/gyn packs
Medical Devices·15 affected·Jun 16, 2022
High RiskFDA
Nordicneurolab As
nordicBrainEX, software versions 2.21 through 2.3.10
Medical Devices·243 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various eye packs, cataract packs
Medical Devices·4 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various neurology packs
Medical Devices·37 affected·Jun 16, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Medical Devices·318 affected·Jun 16, 2022
High RiskFDA
Ge Healthcare, Llc
Centricity PACS Software Version 7.0 SP0.0.4.7
Medical Devices·47 affected·Jun 14, 2022
High RiskFDA
Wright Medical Technology, Inc.
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Medical Devices·231 affected·Jun 14, 2022
High RiskFDA
Sight Diagnostics Ltd
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Medical Devices·72 affected·Jun 14, 2022
RecallFDA
R & D Systems, Inc.
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentration...
Medical Devices·400 affected·Jun 14, 2022
High RiskFDA
Coopersurgical, Inc.
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Medical Devices·403 affected·Jun 13, 2022
High RiskFDA
K2m, Inc.
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Medical Devices·53 affected·Jun 13, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Medical Devices·136 affected·Jun 10, 2022
RecallFDA
Randox Laboratories Ltd.
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Medical Devices·12 affected·Jun 9, 2022
High RiskFDA
Abbott Laboratories
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Medical Devices·103,316 affected·Jun 9, 2022
High RiskFDA
Zeltiq Aesthetics, Inc
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Medical Devices·2,945 affected·Jun 9, 2022
High RiskFDA
Zeltiq Aesthetics, Inc
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Medical Devices·2,684 affected·Jun 9, 2022
High RiskFDA
Zeltiq Aesthetics, Inc
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Medical Devices·703 affected·Jun 9, 2022
RecallFDA
Randox Laboratories Ltd.
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Medical Devices·12 affected·Jun 9, 2022
High RiskFDA
Zeltiq Aesthetics, Inc
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Medical Devices·2,686 affected·Jun 9, 2022
High RiskFDA
Zeltiq Aesthetics, Inc
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Medical Devices·3,054 affected·Jun 9, 2022
High RiskFDA
Ge Healthcare, Llc
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer net...
Medical Devices·1,934 affected·Jun 8, 2022
High RiskFDA
Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, C...
Medical Devices·4,780 affected·Jun 7, 2022
High RiskFDA
Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubi...
Medical Devices·4,780 affected·Jun 7, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ9058...
Medical Devices·288 affected·Jun 6, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A...
Medical Devices·1,880 affected·Jun 6, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SP...
Medical Devices·2,850 affected·Jun 6, 2022
High RiskFDA
Ambu Inc.
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 4123710...
Medical Devices·12,921 affected·Jun 3, 2022
High RiskFDA
Roi Cps Llc
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Medical Devices·86 affected·Jun 3, 2022