RecallHawk

Medical Device Recalls

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

13,633 total recalls

VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

Greiner Bio-One North America, Inc.

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

Microbiologics Inc

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI

Advanced Bionics, LLC

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 S

Medela Inc

Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes

Jiangsu Shenli Medical Production Co., Ltd.

Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 34

Baxter Healthcare Corporation

Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3

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

Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook

B. Braun Medical, Inc.

EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

Red Medical Supplies

PROPONENT SR SL (Model L200)

Boston Scientific Corporation

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Baxter Healthcare Corporation

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

Beckman Coulter, Inc.

Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the Ex

Globus Medical, Inc.

X5-1c Transducer Probe

Philips Ultrasound, Inc

Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

Baxter Healthcare Corporation

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

Intera Oncology, Inc.

LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw sys

Integrity Implants Inc.

OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is de

GE OEC Medical Systems, Inc

ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators

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

Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

AVID Medical, Inc.

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description

Edan Diagnostics

Genesis Knotless Anchor

Aju Pharm Co., Ltd.

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Produ

Angiodynamics, Inc.

Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

Paragon 28, Inc.

FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE

Full Vision Inc

Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy

Stradis Healthcare

Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS78

MEDLINE INDUSTRIES, LP - Northfield

Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.

Wright Medical Technology Inc

Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Windstone Medical Packaging, Inc.

Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301

Biomet, Inc.

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