PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 176 of 548

FDA Devices Moderate Jun 30, 2021

Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & …

Adler MicroMed, Inc.

FDA Devices Moderate Jun 30, 2021

ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Pear Therapeutics, Inc.

FDA Devices Moderate Jun 30, 2021

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented …

Smith & Nephew, Inc.

FDA Devices Moderate Jun 30, 2021

FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

novaplus, General Purpose Kit, Cat. No. 56603

Medical Action Industries, Inc. 306

FDA Devices Moderate Jun 30, 2021

FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Pear Therapeutics, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

VAPORIZER VICKS 1.5GAL Item Number: 2354942

Cardinal Health Inc.

FDA Devices Low Jun 30, 2021

inLight Medical LED Pads used with Polychromatic light technology system

Inlightened Partners LLC

FDA Devices Moderate Jun 30, 2021

Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Philips Medical Systems Nederlands

FDA Devices Moderate Jun 30, 2021

Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and g…

EHOB, Inc.

FDA Devices Moderate Jun 30, 2021

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

BioFire Diagnostics, LLC

FDA Devices Moderate Jun 30, 2021

Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214

Medical Action Industries, Inc. 306

FDA Devices Moderate Jun 30, 2021

6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224

Medical Action Industries, Inc. 306

FDA Drug Moderate Jun 23, 2021

QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou

World Source Llc

FDA Devices Moderate Jun 23, 2021

Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care…

Covidien, LP

FDA Devices Moderate Jun 23, 2021

Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 23, 2021

Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respi…

Covidien, LP

FDA Devices Moderate Jun 23, 2021

Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

Corin Ltd

FDA Devices Moderate Jun 23, 2021

Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

E3800 PC Units (spare parts)

Radiometer Medical ApS

FDA Devices Moderate Jun 23, 2021

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialy…

Medivators, Inc.

FDA Devices Moderate Jun 23, 2021

Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840…

GE Healthcare, LLC

FDA Devices Moderate Jun 23, 2021

VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS…

Bard Peripheral Vascular Inc

FDA Devices Moderate Jun 23, 2021

OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101

Ossur Americas

FDA Devices Moderate Jun 23, 2021

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

Circulatory Technology Inc.

FDA Devices Moderate Jun 23, 2021

Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Radiometer Medical ApS

FDA Devices Moderate Jun 23, 2021

Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

FDA Devices Moderate Jun 23, 2021

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 …

Anodyne Surgical

FDA Devices Moderate Jun 23, 2021

Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems