Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Lumenis, Inc.
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel ...
Medical Devices·11,064 affected·Oct 14, 2021
High RiskFDA
Beeken Biomedical, Llc
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Medical Devices·15 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Medical Devices·38 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Medical Devices·0 affected·Oct 14, 2021
High RiskFDA
Elekta, Inc.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Medical Devices·1,072 affected·Oct 13, 2021
High RiskFDA
Cook Inc.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visua...
Medical Devices·112 affected·Oct 13, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FIL...
Medical Devices·6,653 affected·Oct 12, 2021
High RiskFDA
Clark Laboratories, Inc.
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by quali...
Medical Devices·53 affected·Oct 11, 2021
CriticalFDA
Forbes Rehab Services Inc
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for...
Medical Devices·3,065 affected·Oct 11, 2021
High RiskFDA
Biofire Diagnostics, Llc
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 4...
Medical Devices·14,140 affected·Oct 11, 2021
High RiskFDA
Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Medical Devices·9 affected·Oct 8, 2021
High RiskFDA
Beaver Visitec International, Inc.
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Medical Devices·5,950 affected·Oct 8, 2021
High RiskFDA
Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Medical Devices·52 affected·Oct 8, 2021
High RiskFDA
Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Medical Devices·599 affected·Oct 8, 2021
CriticalFDA
Cook Inc.
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Medical Devices·31,502 affected·Oct 8, 2021
High RiskFDA
Science & Bio Materials
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Medical Devices·72 affected·Oct 7, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 1...
Medical Devices·1,142 affected·Oct 6, 2021
High RiskFDA
Therakos, Inc.
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Medical Devices·5 affected·Oct 4, 2021
High RiskFDA
Ab Sciex
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tande...
Medical Devices·30 affected·Oct 4, 2021
High RiskFDA
Limacorporate S.p.a
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Medical Devices·151 affected·Oct 1, 2021
CriticalFDA
Ellume Ltd
Ellume COVID-19 Home Test
Medical Devices·427,994 affected·Oct 1, 2021
High RiskFDA
Biomerieux, Inc.
API 50 CH, Model 50300
Medical Devices·1,382 affected·Sep 30, 2021
High RiskFDA
Baxter Healthcare Corporation
Hemodialysis Delivery System, Software Version 2.x.
Medical Devices·4,248 affected·Sep 29, 2021
High RiskFDA
Abbott Laboratories
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Medical Devices·20,994 affected·Sep 29, 2021
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorpor...
Medical Devices·48 affected·Sep 28, 2021
High RiskFDA
Elekta Solutions Ab
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552...
Medical Devices·2 affected·Sep 28, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM 1600 Analyzer, SMN 11066000
Medical Devices·1,733 affected·Sep 28, 2021
High RiskFDA
Becton Dickinson & Company
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity t...
Medical Devices·8,000 affected·Sep 27, 2021
High RiskFDA
O&m Halyard Inc
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Medical Devices·2,928 affected·Sep 27, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 7...
Medical Devices·428 affected·Sep 24, 2021
High RiskFDA
Diasorin Molecular Llc
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Medical Devices·1,690 affected·Sep 23, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS RUB IgG (RBG), REF 30226
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS FSH, REF 30407-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS SARS-COV-2 IgM, Ref 423833-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS Estradiol II, REF 30431-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS Lyme IgG II (LYM), REF 417401
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS PRG Progesterone, REF 30409-01
Medical Devices·1,818 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS LH, REF 30406-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Olympus Corporation Of The Americas
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port a...
Medical Devices·350 affected·Sep 21, 2021
CriticalFDA
Datascope Corp.
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the belo...
Medical Devices·131 affected·Sep 21, 2021
High RiskFDA
Smith & Nephew, Inc.
6.5MMX165MM CANNULATED SCREW
Medical Devices·5 affected·Sep 20, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Medical Devices·246 affected·Sep 20, 2021
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c...
Medical Devices·4,405 affected·Sep 17, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit,...
Medical Devices·168 affected·Sep 13, 2021
High RiskFDA
Karl Storz Endoscopy
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Medical Devices·532 affected·Sep 10, 2021
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Foundation Kit
Medical Devices·790 affected·Sep 10, 2021
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
IUD Insertion Pack
Medical Devices·20 affected·Sep 10, 2021