Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Olympus Corporation Of The Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model...
Medical Devices·15,942 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Medical Devices·2,767 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Medical Devices·13,950 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Medical Devices·32,211 affected·Oct 12, 2023
CriticalFDA
Unomedical A/s
VariSoft infusion set, Model Number 1002828
Medical Devices·1,679 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: C...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow ...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Ad...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check A...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Becton Dickinson & Company
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resu...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Becton Dickinson & Company
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PE...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Sunmed Holdings, Llc
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Re...
Medical Devices·0 affected·Oct 11, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
Medical Devices·18,236,160 affected·Oct 10, 2023
High RiskFDA
Beaver Visitec International, Inc.
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Medical Devices·2,160 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Medical Devices·51 affected·Oct 10, 2023
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Medical Devices·0 affected·Oct 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Medical Devices·216 affected·Oct 10, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Medical Devices·1 affected·Oct 9, 2023
High RiskFDA
Philips North America Llc
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and t...
Medical Devices·11 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Philips North America Llc
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Medical Devices·56 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replace...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Medical Devices·1 affected·Oct 9, 2023
High RiskFDA
Biomet, Inc.
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement ...
Medical Devices·0 affected·Oct 9, 2023
High RiskFDA
Advance-esthetic Llc
MED-810A Zemits NDPrime Laser products
Medical Devices·19 affected·Oct 9, 2023
High RiskFDA
Intuitive Surgical, Inc.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Medical Devices·317 affected·Oct 6, 2023
High RiskFDA
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Medical Devices·10 affected·Oct 6, 2023
High RiskFDA
Leoni Cia Cable Systems
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiolo...
Medical Devices·1 affected·Oct 6, 2023
High RiskFDA
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
Medical Devices·63 affected·Oct 6, 2023
High RiskFDA
Carefusion 303, Inc.
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1...
Medical Devices·2,679 affected·Oct 5, 2023
High RiskFDA
Encore Medical, Lp
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Medical Devices·17 affected·Oct 5, 2023
High RiskFDA
Family Dollar Stores, Llc.
MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Visgeneer, Inc.
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bot...
Medical Devices·2,580 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Philips North America
Allura Xper IGTS Fixed Systems
Medical Devices·0 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
FIRST RESPONSE 2 CT, SKU 902343
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Philips North America
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Medical Devices·0 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
Medical Devices·329,044 affected·Oct 4, 2023