RecallHawk

Medical Device Recalls

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

13,600 total recalls

Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed fo

Philips North America Llc

The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination o

Beckman Coulter, Inc.

DeRoyal EYE PACK, REF 89-4051.09

DeRoyal Industries Inc

BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿

Becton Dickinson & Co.

Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, P

MEDLINE INDUSTRIES, LP - Northfield

Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety In

B. Braun Medical, Inc.

BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

CareFusion 303, Inc.

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

MEDLINE INDUSTRIES, LP - Northfield

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP,

Smiths Medical ASD Inc.

MAGNETOM Verio Dot. Model Number: 10684333.

Siemens Medical Solutions USA, Inc

Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) D

Medtronic Perfusion Systems

Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012,

GE Healthcare

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. F

Cook Incorporated

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Integra LifeSciences Corp.

Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

Olympus Corporation of the Americas

Accure Laser System, Model: PFMS00004

Accure Acne, Inc

BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene

Becton Dickinson & Co.

Premier Rotaclone, Rx only

MEDLINE INDUSTRIES, LP - Northfield

VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

bioMerieux, Inc.

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device

Carefusion 2200 Inc

BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

Becton Dickinson & Co.

Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile sy

Jiangsu Shenli Medical Production Co., Ltd.

Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical dev

Immunotech A.S.

Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilitie

ZOLL Circulation, Inc.

BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transportin

Becton Dickinson & Company

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240

Bard Access Systems, Inc.

Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

BARCO NV

GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

MicroPort Orthopedics Inc.

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