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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 941–960 of 1,000 recalls

Class IOngoing

BD Alaris Syringe Module, REF 8110

CareFusion 303, Inc.

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

September 15, 2023 · DeviceView details →
Class IOngoing

BD Alaris PCU REF 8015

CareFusion 303, Inc.

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

September 15, 2023 · DeviceView details →
Class I
Ongoing

Astral 100 and Astral 150 ventilators

ResMed Ltd.

If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all

September 13, 2023 · DeviceView details →
Class IOngoing

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

EITAN MEDICAL LTD

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

September 11, 2023 · DeviceView details →
Class IOngoing

2008T HD SYS. W/O CDX BLUESTAR

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T Hemodialysis SYS, with CDX

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T Hemodialysis System w/Bibag

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T GEN 2 Bibag without CDX

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T HD SYS. CDX W/BIBAG BLUESTAR

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T Hemodialysis System without CDX

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

2008T HD SYS. CDX BLUESTAR

Fresenius Medical Care Holdings, Inc.

Potential PCBA leaching from tubing of hemodialysis machines.

September 6, 2023 · DeviceView details →
Class IOngoing

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

Philips Respironics, Inc.

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

August 25, 2023 · DeviceView details →
Class IOngoing

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days

ARROW INTERNATIONAL Inc.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

August 10, 2023 · DeviceView details →
Class IOngoing

Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

ARROW INTERNATIONAL Inc.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

August 10, 2023 · DeviceView details →
Class IOngoing

Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter

ARROW INTERNATIONAL Inc.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

August 10, 2023 · DeviceView details →
Class IOngoing

Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

ARROW INTERNATIONAL Inc.

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

August 10, 2023 · DeviceView details →
Class IOngoing

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

Fresenius Medical Care Holdings, Inc.

There is a potential for blood backfill leakage and foreign material.

August 8, 2023 · DeviceView details →
Class IOngoing

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Fresenius Medical Care Holdings, Inc.

There is a potential for blood backfill leakage and foreign material.

August 8, 2023 · DeviceView details →
Class IOngoing

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Fresenius Medical Care Holdings, Inc.

There is a potential for blood backfill leakage and foreign material.

August 8, 2023 · DeviceView details →
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