Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotat
ICU Medical, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001753;
Beaver Visitec International, Inc.
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units pe
ConMed Corporation
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit
Medline Industries, LP
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version
Abbott Diagnostics Scarborough, Inc.
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 4
ConvaTec, Inc
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Medline Industries, LP
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Becton Dickinson & Co.
Artegraft Vascular Graft; REF#: AG740;
LeMaitre Vascular, Inc.
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Ret
Synthes (USA) Products LLC
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model N
MEDLINE INDUSTRIES, LP - Northfield
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G013
Cook Incorporated
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pac
MEDLINE INDUSTRIES, LP - Northfield
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
CareFusion 303, Inc.
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
MEDLINE INDUSTRIES, LP - Northfield
Cath Lab Pack, CECL02P; Medical convenience kit
American Contract Systems, Inc.
Philips X5-1 Transducer.
Philips Ultrasound, Inc
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Si
CooperVision, Inc.
CRE Wireguided 8-10mm 240cm
Boston Scientific Corporation
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod
Abiomed, Inc.
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile
Jiangsu Shenli Medical Production Co., Ltd.
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65
TriMed Inc.
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi
Fisher & Paykel Healthcare, Ltd.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product
Draeger, Inc.
FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
Mckesson Medical-Surgical Inc. Corporate Office
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
T.G. Eakin Limited
IQon Spectral CT IQon Spectral CT Upgrades
PHILIPS MEDICAL SYSTEMS
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Mode
Boston Scientific Corporation
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTA
MEDLINE INDUSTRIES, LP - Northfield
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