Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 94 of 548
FDA Devices Moderate Dec 27, 2023
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, au…
Abbott Laboratories
FDA Devices Critical Dec 27, 2023
AirFit F30 Full Face Mask and User Guide
ResMed Ltd.
FDA Devices Critical Dec 27, 2023
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV …
Nurse Assist, LLC
FDA Devices Critical Dec 27, 2023
AirFit N10 Nasal Masks and User Guide
ResMed Ltd.
FDA Devices Moderate Dec 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in …
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Dec 27, 2023
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Zeus Scientific, Inc.
FDA Devices Moderate Dec 27, 2023
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g)…
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body…
Philips North America Llc
FDA Devices Moderate Dec 27, 2023
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Maquet Medical Systems USA
FDA Devices Moderate Dec 27, 2023
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3…
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) …
Exactech, Inc.
FDA Devices Critical Dec 27, 2023
AirFit F20 Full Face Mask and User Guide
ResMed Ltd.
FDA Food Critical Dec 20, 2023
Wilcox Premium Pumpkin in 1.5QT, Quart, Pint, and 3 Gallon sizes
WILCOX ICE CREAM
FDA Devices Moderate Dec 20, 2023
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Encore Medical, LP
FDA Devices Moderate Dec 20, 2023
STERILE PVP SOLUTION, REF DYNDA1907
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-52…
Riverpoint Medical, LLC
FDA Devices Moderate Dec 20, 2023
Medline Leg bag, REF URO12573
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
STERILE POVIDONE, REF DYNDA2061
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
Medline Leg bag, REF DYND12574
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray gen…
GE Hangwei Medical Systems, Co. LTD
FDA Devices Critical Dec 20, 2023
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Sy…
Philips North America Llc
FDA Devices Moderate Dec 20, 2023
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
CHANGE HEALTHCARE CANADA COMPANY
FDA Devices Moderate Dec 20, 2023
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023
STERILE BETADINE, REF DYNDA1998
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing int…
Meridian Bioscience Inc
FDA Devices Moderate Dec 20, 2023
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Olympus Corporation of the Americas
FDA Devices Low Dec 20, 2023
Navik 3D v2, REF NAVIK3D, 3D Mapping System
APN Health LLC
FDA Devices Moderate Dec 20, 2023
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites C…
Meridian Bioscience Inc
FDA Devices Moderate Dec 20, 2023
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Baxter Healthcare Corporation
FDA Devices Moderate Dec 20, 2023
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Limacorporate S.p.A
FDA Devices Moderate Dec 20, 2023
Medline Leg bag, REF DYND12578
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass ci…
Maquet Medical Systems USA
FDA Devices Moderate Dec 20, 2023
STERILE PVP, REF DYNDA1649
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen…
BioReference Health, LLC
FDA Devices Moderate Dec 20, 2023
STERILE STERILE PREP STICK, REF DYNDA1134
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray gen…
GE Hangwei Medical Systems, Co. LTD
FDA Devices Moderate Dec 20, 2023
Medtronic SynchroMed, Model A10
Medtronic Inc.
FDA Devices Moderate Dec 13, 2023
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
FDA Devices Moderate Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect …
CooperSurgical, Inc.
FDA Devices Moderate Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.