Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,600 total recalls
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A
Medline Industries, LP
PREGNANCY TEST 24CT
GOLD STAR DISTRIBUTION INC
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001695;
Beaver Visitec International, Inc.
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Medtronic Sofamor Danek USA Inc
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo
GE Healthcare, LLC
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic S
Think Surgical, Inc.
Philips X7-2 Ultrasound Transducer
Philips Ultrasound, Inc
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
Philips North America Llc
ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa
B Braun Medical Inc
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
ASO LLC
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i
Beckman Coulter, Inc.
DeRoyal BREAST TRAY, REF 89-7033.07
DeRoyal Industries Inc
Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC013
Total Resources Intl
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe
Medline Industries, LP
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Hobbs Medical, Inc.
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
B Braun Medical Inc
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
Stryker Corporation
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
TELEFLEX LLC
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Medacta Usa Inc
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical
Instrumentation Laboratory
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
GE Medical Systems, SCS
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
Biomerieux Inc
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Numbe
Cypress Medical Products LLC
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
ARROW INTERNATIONAL Inc.
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-
Olympus Corporation of the Americas
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
SEDECAL SA
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Medline Industries, LP
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/
Medline Industries, LP
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