Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,606 total recalls
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 008500
Stryker Corporation
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery.
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001484;
Beaver Visitec International, Inc.
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
AVID Medical, Inc.
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical,
Stradis Healthcare
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
SEDECAL SA
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbod
Stryker Spine
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Encore Medical, LP
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1
Philips North America
CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
CooperVision Inc.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Howmedica Osteonics Corp.
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Straumann USA LLC
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chi
Cardinal Health 200, LLC
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va
Cook Incorporated
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medl
Medline Industries, LP
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descri
Abbott Diagnostics Scarborough, Inc.
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Philips North America Llc
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND
MEDLINE INDUSTRIES, LP - Northfield
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
Busse Hospital Disposables, Inc.
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Covidien
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
DeVilbiss Healthcare LLC
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Merit Medical Systems, Inc.
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode
Medline Industries, LP
SIGNA Artist nuclear magnetic resonance imaging system
GE Healthcare, LLC
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Philips North America Llc
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELV
Medline Industries, LP
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Versio
Guangzhou Pluslife Biotech Co., Ltd.
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Staar Surgical Company
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack A
ASO LLC
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG
Biomet, Inc.
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