Medical Device Recalls

Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa

Philips Respironics, Inc.

SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Mag

GE Medical Systems, LLC

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)

Stryker Neurovascular

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

Siemens Healthcare Diagnostics, Inc.

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral va

ev3 Inc.

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid

Aizu Olympus Co., Ltd.

Genesis Dual Thread Screw-In Anchor

Aju Pharm Co., Ltd.

NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood,

Mc3 Inc

ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S

American Contract Systems Inc

R82 by ETAC Push Brace for High-Low

R82 A/S

Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting

Getinge Usa Sales Inc

Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TIS

MEDLINE INDUSTRIES, LP - Northfield

Accelerate PhenoTest BC kit REF 10102018

Accelerate Diagnostics Inc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYN

MEDLINE INDUSTRIES, LP - Northfield

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMEN

Boston Scientific Neuromodulation Corporation

IBA Proton Therapy System - PROTEUS 235

Ion Beam Applications S.A.

8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171

Intuitive Surgical, Inc.

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

Remel Inc

CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators

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

MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHE

Siemens Medical Solutions USA, Inc

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backche

Baxter Healthcare Corporation

Philips OMNI III TEE Ultrasound Transducer

Philips Ultrasound, Inc

Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Philips Ultrasound Inc

Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS98

MEDLINE INDUSTRIES, LP - Northfield

CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte sp

Cytocell Ltd.

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Softwa

Draeger, Inc.

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

Outset Medical, Inc.

Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPE

MEDLINE INDUSTRIES, LP - Northfield