Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 102 of 548
FDA Devices Critical Oct 11, 2023
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter,…
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
GS0008 2Y - Burn Pack - STL, Item Number 880082025
ROi CPS LLC
FDA Devices Moderate Oct 11, 2023
Incisive CT, software version 5.0
Philips Healthcare
FDA Devices Moderate Oct 11, 2023
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
AB Sciex, LLC
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
AB Sciex, LLC
FDA Devices Moderate Oct 11, 2023
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Track…
Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Becton Dickinson Infusion Therapy Systems Inc.
FDA Devices Moderate Oct 11, 2023
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System …
Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Philips North America Llc
FDA Devices Moderate Oct 11, 2023
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Oct 11, 2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Medtronic Neuromodulation
FDA Devices Moderate Oct 11, 2023
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro s…
DKK Dai-Ichi Shomei Co., Ltd.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
GE Medical Systems China Co., Ltd.
FDA Devices Moderate Oct 11, 2023
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Ne…
Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Blue Belt Technologies, Inc
FDA Devices Moderate Oct 11, 2023
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temp…
Icecure Medical Ltd
FDA Devices Moderate Oct 11, 2023
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Covidien
FDA Devices Moderate Oct 11, 2023
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in …
Qiagen GmbH
FDA Devices Moderate Oct 11, 2023
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Mo…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 11, 2023
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stell…
DKK Dai-Ichi Shomei Co., Ltd.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Critical Oct 11, 2023
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-t…
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Thoratec Corp.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
API3200MD Mass Spectrometer, Part Number 4466230
AB Sciex, LLC
CPSC Moderate Oct 5, 2023
CURiO Recalls Capri Blue Pet Products Due to Risk of Exposure to Bacteria (Recall Alert)
CURiO Brands LLC, of Minneapolis, Minnesota
FDA Devices Moderate Oct 4, 2023
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
3M Company - Health Care Business
FDA Devices Moderate Oct 4, 2023
BD Pyxis MedBank MedPass Software, REF: 139088-01
CareFusion 303, Inc.
FDA Devices Critical Oct 4, 2023
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Philips Respironics, Inc.
FDA Devices Moderate Oct 4, 2023
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the vol…
WOM World Of Medicine AG
FDA Devices Moderate Oct 4, 2023
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the…
B. Braun Medical, Inc.
FDA Devices Moderate Oct 4, 2023
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Baxter Healthcare Corporation
FDA Devices Moderate Oct 4, 2023
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of…
Exocad GmbH
FDA Devices Moderate Oct 4, 2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endosco…
Ambu Inc.
FDA Devices Moderate Oct 4, 2023
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Stryker Corporation
FDA Devices Moderate Oct 4, 2023
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
J&T Health and Wellness LLC
FDA Devices Moderate Oct 4, 2023
Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 …
Inmar Supply Chain Solutions, LLC
FDA Devices Moderate Oct 4, 2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body…
B. Braun Medical, Inc.
FDA Devices Moderate Oct 4, 2023
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Covidien LP
FDA Devices Moderate Oct 4, 2023
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Waldemar Link GmbH & Co. KG (Mfg Site)
FDA Devices Moderate Oct 4, 2023
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization process…
3M Company - Health Care Business