RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,617 total recalls

Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter

Boston Scientific Corporation

GE Heathcare Giraffe OmniBed; neo natal incubator

DATEX--OHMEDA, INC.

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYND

MEDLINE INDUSTRIES, LP - Northfield

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter

Boston Scientific Corporation

CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,

Stryker Corporation

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, l

Olympus Corporation of the Americas

Brivo MR355, NMRI system

GE Healthcare (China) Co., Ltd.

CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

Karl Storz Endoscopy

Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product De

CooperSurgical, Inc.

MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display

Barco N.V.

Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

Datascope Corp.

EVIS EXERA III Bronchovideoscope

Aizu Olympus Co., Ltd.

Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT P

MEDLINE INDUSTRIES, LP - Northfield

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075

TELEFLEX LLC

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following u

Smiths Medical ASD Inc.

Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se

Oridion Medical 1987 Ltd.

Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V

Abbott Diagnostics Scarborough, Inc.

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

Stryker Sustainability Solutions

KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in cli

Olympus Corporation of the Americas

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;

Beaver Visitec International, Inc.

ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

Abbott GmbH

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre

Merit Medical Systems, Inc.

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment o

Becton Dickinson & Company

Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH

MEDLINE INDUSTRIES, LP - Northfield

Atlan A350XL. Model Number: 8621600. anesthesia workstation

Draeger, Inc.

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