Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 86 of 548
FDA Devices Critical Mar 6, 2024
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Vyaire Medical
FDA Devices Critical Mar 6, 2024
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid…
Medtronic Neurosurgery
FDA Devices Moderate Mar 6, 2024
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences Corp.
FDA Devices Moderate Mar 6, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
EMD Millipore Corporation
FDA Devices Critical Mar 6, 2024
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Mar 6, 2024
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plat…
Acumed LLC
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number PCF-Q180AL.
Olympus Corporation of the Americas
FDA Devices Moderate Mar 6, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences Corp.
FDA Devices Critical Mar 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Vyaire Medical
FDA Devices Critical Mar 6, 2024
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND4…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CAR…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Mar 6, 2024
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient u…
Zyno Medical LLC
FDA Devices Moderate Mar 6, 2024
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125,…
United Orthopedic Corporation
FDA Devices Low Mar 6, 2024
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Abbott Molecular, Inc.
FDA Devices Critical Mar 6, 2024
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Mar 6, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cer…
Medtronic Neurosurgery
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number CF-HQ190I.
Olympus Corporation of the Americas
FDA Devices Critical Mar 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
Vyaire Medical
FDA Devices Critical Mar 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
Vyaire Medical
FDA Devices Moderate Mar 6, 2024
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Parker Laboratories, Inc.
FDA Devices Low Mar 6, 2024
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Pro…
Abbott Molecular, Inc.
FDA Devices Critical Feb 28, 2024
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Cardinal Health 200, LLC
FDA Devices Critical Feb 28, 2024
TRACH KIT W/HYDROGEN & SALI
Cardinal Health 200, LLC
FDA Devices Moderate Feb 28, 2024
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
AMD Medicom Inc.
FDA Devices Moderate Feb 28, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administra…
B. Braun Medical, Inc.
FDA Devices Critical Feb 28, 2024
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY,…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 28, 2024
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatm…
PTW-FREIBURG
FDA Devices Moderate Feb 28, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: Fle…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Fl…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Feb 28, 2024
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Windstone Medical Packaging, Inc.
FDA Devices Critical Feb 28, 2024
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Cardinal Health 200, LLC
FDA Devices Moderate Feb 28, 2024
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascu…
Abiomed, Inc.
FDA Devices Moderate Feb 28, 2024
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 28, 2024
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
AMD Medicom Inc.
FDA Devices Moderate Feb 28, 2024
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user in…
Canon Medical System, USA, INC.
FDA Devices Moderate Feb 28, 2024
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number …
W.L. Gore & Associates, Inc.
FDA Devices Moderate Feb 28, 2024
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Voco GmbH
FDA Devices Critical Feb 28, 2024
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 28, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRa…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 28, 2024
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
FUJIFILM Healthcare Americas Corporation
FDA Devices Critical Feb 28, 2024
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Windstone Medical Packaging, Inc.
FDA Devices Moderate Feb 28, 2024
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Feb 28, 2024
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LO…
Cardinal Health 200, LLC