Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Medical Devices·1,133,612 affected·Apr 29, 2022
High RiskFDA
Isopure Corp
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Medical Devices·119 affected·Apr 28, 2022
High RiskFDA
Ge Healthcare, Llc
Centricity Radiology RA600
Medical Devices·1,332 affected·Apr 28, 2022
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer Zero Footprint Client
Medical Devices·488 affected·Apr 28, 2022
High RiskFDA
Ge Healthcare, Llc
Centricity Enterprise Web
Medical Devices·536 affected·Apr 28, 2022
High RiskFDA
Micro Therapeutics, Inc.
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Medical Devices·96 affected·Apr 27, 2022
High RiskFDA
Beaver Visitec International, Inc.
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical curr...
Medical Devices·660 affected·Apr 26, 2022
High RiskFDA
Daavlin Distributing Company
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305...
Medical Devices·216 affected·Apr 26, 2022
High RiskFDA
Ge Healthcare, Llc
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Medical Devices·6,612 affected·Apr 25, 2022
High RiskFDA
Convatec, Inc
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Medical Devices·600 affected·Apr 22, 2022
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duode...
Medical Devices·8 affected·Apr 22, 2022
High RiskFDA
Olympus Corporation Of The Americas
Colonovideoscope Model CF-H180AL
Medical Devices·1 affected·Apr 22, 2022
High RiskFDA
Ivenix, Inc.
Ivenix Infusion System (IIS)
Medical Devices·1,335 affected·Apr 22, 2022
High RiskFDA
Smith & Nephew Orthopaedics Gmbh
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Medical Devices·17 affected·Apr 22, 2022
High RiskFDA
Baxter Healthcare Corporation
3,65 m Extension Set with Luer-lock Connector
Medical Devices·60 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
15 Liters Drain Bag
Medical Devices·510 affected·Apr 21, 2022
High RiskFDA
Dain Technology, Inc. (subsidiary Of Soundable Health, Inc.)
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Medical Devices·41 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
APD Drain Manifold
Medical Devices·180 affected·Apr 21, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Medical Devices·4,033 affected·Apr 21, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
Medical Devices·500 affected·Apr 21, 2022
High RiskFDA
Oakworks Inc
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
Medical Devices·130 affected·Apr 21, 2022
High RiskFDA
Oakworks Inc
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
Medical Devices·109 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
5 Prong Manifold Set (with Luer Connectors)
Medical Devices·180 affected·Apr 21, 2022
High RiskFDA
Ion Beam Applications S.a.
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other co...
Medical Devices·4 affected·Apr 20, 2022
High RiskFDA
Olympus Corporation Of The Americas
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Medical Devices·4 affected·Apr 20, 2022
High RiskFDA
Progenacare
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM300...
Medical Devices·547 affected·Apr 18, 2022
CriticalFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500...
Medical Devices·65,093 affected·Apr 18, 2022
CriticalFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model...
Medical Devices·58,671 affected·Apr 18, 2022
High RiskFDA
Proterixbio
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Medical Devices·640 affected·Apr 17, 2022
High RiskFDA
Medacta Usa Inc
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Medical Devices·50 affected·Apr 13, 2022
High RiskFDA
Baxter Healthcare Corporation
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and eme...
Medical Devices·1,414 affected·Apr 13, 2022
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR...
Medical Devices·3,944 affected·Apr 12, 2022
High RiskFDA
Umano Medical, Inc.
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Medical Devices·228 affected·Apr 11, 2022
High RiskFDA
Teleflex Medical Inc
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Hu...
Medical Devices·59,581 affected·Apr 11, 2022
High RiskFDA
Umano Medical, Inc.
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Medical Devices·355 affected·Apr 11, 2022
High RiskFDA
Radiometer Medical Aps
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, ...
Medical Devices·7,228 affected·Apr 8, 2022
High RiskFDA
Instrumentation Laboratory
HemosIL ReadiPlasTin, Part No. 0020301400
Medical Devices·1,563 affected·Apr 8, 2022
High RiskFDA
Xvivo Perfusion Ab
XVIVO Organ Chamber REF 19020
Medical Devices·80 affected·Apr 8, 2022
High RiskFDA
Microtek Medical Inc.
TMJ Arthroscopy Drape, 85''x 96''
Medical Devices·12 affected·Apr 8, 2022
High RiskFDA
Malvern Panalytical Ltd
NanoSight NS300
Medical Devices·507 affected·Apr 7, 2022
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Medical Devices·0 affected·Apr 6, 2022
High RiskFDA
Luminex Corporation
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Medical Devices·24 affected·Apr 5, 2022
High RiskFDA
Certified Safety Mfg Inc
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/b...
Medical Devices·14,685 affected·Apr 5, 2022
High RiskFDA
Karl Storz Endoscopy
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278AC...
Medical Devices·2,018 affected·Apr 1, 2022
CriticalFDA
Celltrion Usa Inc
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Medical Devices·12,632 affected·Apr 1, 2022
High RiskFDA
Baxter Healthcare Corporation
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide...
Medical Devices·300 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE ...
Medical Devices·2,018 affected·Apr 1, 2022