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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Philips pressure and mechanical ventilator devices - recalled due to health risks, USA

4 years ago •source fda.gov • details

Company name: Philips
Brand name: Philips
Product recalled: Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices
Reason of the recall: Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices
FDA Recall date:… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator - recalled due to defective applicator, USA

4 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: ChloraPrep
Product recalled: ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator
Reason of the recall: Defective applicator
FDA Recall date: April 20, 2021
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots… See more

#recall #medicaldevices #blood #unitedstates #orange

312   Comments Comment

Recall notice

Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially weakened elastic, USA

4 years ago •source fda.gov • details

Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore… See more

#medicaldevices #unitedstates

Recalls Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially w... photo #1
313   Comments Comment

Recall notice

Medtronic Valiant Navion™ Thoracic stent graft system - recalled due to endoleaks, stent fractures and stent ring enlargement, USA

5 years ago •source fda.gov • details

Company name: Medtronic
Brand name: Medtronic Valiant Navion™
Product recalled: Thoracic stent graft system
Reason of the recall: Due to endoleaks, stent fractures and stent ring enlargement
FDA Recall date: February 23, 2021
Recall details: Medtronic plc (NYSE:MDT), the global leader in medical technology, has voluntarily issued… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

Wahl Clipper Deluxe Heat Therapy Massagers - recalled due to fire hazard, USA

5 years ago •source fda.gov • details

Company name: Wahl Clipper Corporation
Brand name: Wahl
Product recalled: Deluxe Heat Therapy Massagers, Model 4212
Reason of the recall: Can overheat causing smoke or spark, which may pose a fire hazard
FDA Recall date: January 28, 2021
Recall details: Wahl Clipper Corporation is voluntarily recalling all… See more

#medicaldevices #unitedstates

Recalls Wahl Clipper Deluxe Heat Therapy Massagers - recalled due to fire hazard Company name: Wahl Clipper... photo #1
312   Comments Comment

Recall notice

Boston Scientific Corporation LOTUS Edge™ Aortic Valve System - recalled due to Delivery System Issues Potential inability to release the delivery system, USA

5 years ago •source fda.gov • details

Company name: Boston Scientific Corporation
Brand name: LOTUS Edge™ Aortic Valve System
Product recalled: LOTUS Edge™ Aortic Valve System
Reason of the recall: Delivery System Issues Potential inability to release the delivery system
FDA Recall date: January 11, 2021
Recall details: Boston Scientific Corporation (NYSE: BSX) has… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

Sigma Spectrum Infusion Pumps - recalled due to deviations from the specified cleaning methods may impair infusion pump, USA

5 years ago •source fda.gov • details

Company name: Baxter International Inc.
Brand name: Sigma Spectrum
Product recalled: Infusion Pumps
Reason of the recall: Deviations from the specified cleaning methods may impair infusion pump
FDA Recall date: October 29, 2020
Recall details: Baxter International Inc. announced today it has issued an Urgent Device Correction… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

BD Alaris System Hardware - recalled due to Potential for four hardware situations that may result in the infusion pump not operating as expected, USA

5 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: BD Alaris System Hardware
Reason of the recall: Potential for four hardware situations that may result in the infusion pump not operating as expected
FDA Recall date: September 21, 2020
Recall details: Three Recalls Designated as… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

Alaris Infusion Pump - recalled due to Hardware issues may cause the infusion pump to not operate as expected, USA

5 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: Alaris Infusion Pump
Reason of the recall: Hardware issues may cause the infusion pump to not operate as expected
FDA Recall date: September 01, 2020
Recall details: Majority of June 30 Recall Designated as Class I… See more

#medicaldevices #unitedstates

312   Comments Comment

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