FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 201–220 of 1,000 recalls

Class IITerminated

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Fresenius Medical Care Holdings, Inc.

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

May 4, 2022 · DeviceView details →

Class IITerminated

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

MicroPort Orthopedics Inc.

One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

May 4, 2022 · DeviceView details →

FDA Device Recalls

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

FIRMap" Catheter, 60mm Basket

In-Line ventilator adaptor

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

In-Line ventilator adaptor

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

Colonovideoscope Model CF-H180AL

Ivenix Infusion System (IIS)

Reliance Synergy Washer/Disinfector

3,65 m Extension Set with Luer-lock Connector

15 Liters Drain Bag

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

APD Drain Manifold

Locking Cap for PD Catheter Adapter