Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 152 of 548
FDA Devices Moderate May 18, 2022
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V …
Daavlin Distributing Company
FDA Devices Moderate May 18, 2022
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinu…
Certified Safety Mfg Inc
FDA Devices Moderate May 18, 2022
TMJ Arthroscopy Drape, 85''x 96''
Microtek Medical Inc.
FDA Devices Moderate May 18, 2022
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM0…
Medtronic Vascular, Inc.
FDA Devices Moderate May 18, 2022
Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical, LLC
FDA Devices Moderate May 18, 2022
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031U…
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
American Contract Systems, Inc.
FDA Devices Moderate May 18, 2022
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate May 11, 2022
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary…
Baxter Healthcare Corporation
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 11, 2022
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Johnson & Johnson Surgical Vision Inc
FDA Devices Moderate May 11, 2022
K-Wire, 1.35 mm x 170 mm
Arthrex, Inc.
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 11, 2022
Restrata, Part Number RWM1-2X2
Acera Surgical Inc
FDA Devices Moderate May 11, 2022
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
restor3d Inc.
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 11, 2022
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas
FDA Devices Moderate May 11, 2022
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Becton Dickinson & Co.
FDA Devices Moderate May 11, 2022
VELYS Robotic-Assisted Solution Base Product No.: 451570100
DePuy Orthopaedics, Inc.
FDA Devices Moderate May 11, 2022
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical in…
restor3d Inc.
FDA Devices Moderate May 11, 2022
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
restor3d Inc.
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 4, 2022
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 …
Intuitive Surgical, Inc.
FDA Devices Critical May 4, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
FDA Devices Moderate May 4, 2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Freudenberg Medical, Llc
FDA Devices Moderate May 4, 2022
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during rad…
Boston Scientific Corporation
FDA Devices Moderate May 4, 2022
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate May 4, 2022
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for p…
Boston Scientific Corporation
FDA Devices Moderate May 4, 2022
Smart Toe II Intramedullary Arthrodesis Implant
Stryker GmbH
FDA Devices Moderate May 4, 2022
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother;…
ROi CPS LLC
FDA Devices Moderate May 4, 2022
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Draegar Medical Systems, Inc.
FDA Devices Moderate May 4, 2022
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 4, 2022
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upg…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 4, 2022
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Carl Zeiss Meditec AG
FDA Devices Moderate May 4, 2022
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 4, 2022
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
ROi CPS LLC
FDA Devices Critical May 4, 2022
Puritan Bennett 980 Series Ventilator
Medtronic formerly Covidien
FDA Devices Moderate May 4, 2022
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3…
Instrumentation Laboratory
FDA Devices Moderate May 4, 2022
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Baxter Healthcare Corporation
FDA Devices Moderate May 4, 2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Freudenberg Medical, Llc
FDA Devices Moderate May 4, 2022
PrisMax System, Product Code 955724
Baxter Healthcare Corporation
FDA Devices Moderate May 4, 2022
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) T…
Medtronic Neuromodulation
FDA Devices Moderate May 4, 2022
WAVES WCM Kidney Cassette Module
Waters Medical Systems LLC
FDA Devices Critical Apr 27, 2022
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
Respironics California, LLC
FDA Devices Moderate Apr 27, 2022
Virus Counter Platform with Model Name VC3100
Sartorius Corporation
FDA Devices Moderate Apr 27, 2022
Artis zee floor MN, Model Number 10094142
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Artis Q ceiling, Model Number 10848281
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Artis Q zeego, Model Number 10848283
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Artis Q.zen floor, Model Number 10848353
Siemens Medical Solutions USA, Inc