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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