RecallHawk

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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