Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resona
GE Healthcare, LLC
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/U
Angiodynamics, Inc.
KNEE SCOPE Procedure tray Catalog Number: COKN48L
American Contract Systems Inc
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B
ROi CPS LLC
Puritan Bennett 980 Series Ventilator
Medtronic formerly Covidien
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Baxter Healthcare Corporation
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV
Medline Industries, LP
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
MEDLINE INDUSTRIES, LP - Northfield
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
AVID Medical, Inc.
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
Boston Scientific Corporation
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tis
Mentor Texas, LP.
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Stradis Medical, LLC dba Stradis Healthcare
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech r
Exactech, Inc.
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Stryker Corporation
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108
Hobbs Medical, Inc.
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
MEDLINE INDUSTRIES, LP - Northfield
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.
Siemens Medical Solutions USA, Inc.
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Olympus Corporation of the Americas
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111
Philips Respironics, Inc.
ARTIS icono ceiling. Model Number: 11328100.
Siemens Medical Solutions USA, Inc
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Cook Incorporated
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Intuitive Surgical, Inc.
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNEL
MEDLINE INDUSTRIES, LP - Northfield
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. f
Fresenius Kabi USA, LLC
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115
Medtronic Sofamor Danek USA Inc
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIAL
MEDLINE INDUSTRIES, LP - Northfield
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Ma
CooperSurgical, Inc.
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786
GE Healthcare Finland Oy
GEM Premier 5000 PAK; Part No. 00055407508.
Instrumentation Laboratory
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap,
ICU Medical, Inc.
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