RecallHawk

Medical Device Recalls

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

13,617 total recalls

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter

Boston Scientific Corporation

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333

United Orthopedic Corp.

CRE Pro Wireguided 12-15mm 240cm

Boston Scientific Corporation

GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000

Wipro GE Healthcare Private Ltd.

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

TERRAGENE S.A.

Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

Shimadzu Corp. Analytical & Measuring Instruments Div.

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

IMPRIS Imaging Inc

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

Medtronic Neuromodulation

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

Shimadzu Medical Systems

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;

Beaver Visitec International, Inc.

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

Medline Industries, LP

Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a

Abbott Medical

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-0

Datascope Corp.

Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112

Carefusion 2200 Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;

Beaver Visitec International, Inc.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164;

Windstone Medical Packaging, Inc.

Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile sy

Jiangsu Shenli Medical Production Co., Ltd.

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90

Medtronic Neuromodulation

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou

Olympus Corporation of the Americas

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, re

Stryker Instruments Div. of Stryker Corporation

ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449

Biomerieux Inc

3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam ster

3M Company - Health Care Business

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Remote Diagnostic Technologies Ltd.

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele

Elekta, Inc.

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 610

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883

Covidien LP

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips

TELEFLEX LLC

Pacemaker, COPM11B; Medical convenience kit

American Contract Systems, Inc.

Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

SA3, LLC

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