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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