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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Endologix® Inc. Ovation iX Stent Graft system - recalled due to material weakness, United States

5 years ago •source fda.gov • details

Company name: Endologix® Inc.
Brand name: Ovation
Product recalled: Ovation iX system
Reason of the recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
FDA Recall date: July 08, 2020
Recall details: Company Announcement Endologix® Inc. (Nasdaq: ELGX)… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potentially could cause over-infusion or under-infusion of therapy, USA

5 years ago •source fda.gov • details

Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME America, a wholly owned… See more

#medicaldevices #unitedstates

Recalls Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potential... photo #1
312   Comments Comment

Recall notice

Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance, USA

5 years ago •source fda.gov • details

Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated… See more

#medicaldevices #unitedstates

Recalls Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance Comp... photo #1
312   Comments Comment

Recall notice

Allergan Aesthetics Breast Implants - recalled due to Increased risk of BIA-ALCL, USA

5 years ago •source fda.gov • details

Company name: Allergan Aesthetics
Brand name: BIOCELL
Product recalled: Breast Implants
Reason of the recall: Increased risk of BIA-ALCL
FDA Recall date: June 01, 2020
Recall details: Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

Infusion pumps and sets - recalled due to pumps may not deliver fluid at the accuracy specified in the instructions, USA

5 years ago •source fda.gov • details

Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall details:… See more

#medicaldevices #unitedstates #evolve

Recalls Infusion pumps and sets - recalled due to pumps may not deliver fluid at the accuracy specified in t... photo #1
312   Comments Comment

Regulatory Report

TRUE METRIX® AIR Blood Glucose Meter - recalled due to Incorrect factory-set unit of measure, Fort Lauderdale, Florida, United States

5 years ago •source fda.gov • details

Company name: Trividia Health, Inc.
Brand name: TRUE METRIX
Product recalled: TRUE METRIX® AIR Blood Glucose Meter
Reason of the recall: Incorrect factory-set unit of measure
FDA Recall date: April 21, 2020
Recall details: Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of… See more

#medicaldevices #blood #fortlauderdale #florida #unitedstates

144   Comments Comment

Regulatory Report

Becton, Dickinson, and Company BD Alaris System PC Units and Modules - recalled due to Infusion pump may not operate as expected, Franklin Lakes, New Jersey, United States

5 years ago •source fda.gov • details

Company name: Becton, Dickinson, and Company
Brand name: BD Alaris
Product recalled: BD Alaris System PC Units and Modules
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: March 10, 2020
Recall details: BD (Becton, Dickinson and Company), a leading global medical… See more

#medicaldevices #recall #franklinlakes #newjersey #unitedstates

5   Comments Comment

Regulatory Report

Advanced Bionics Cochlear implants - recalled due to Reports of hearing performance degradation, Valencia, Santa Clarita, CA, USA

5 years ago •source fda.gov • details

Company name: Advanced Bionics
Brand name: HiRes Ultra and Ultra 3D
Product recalled: Cochlear implants
Reason of the recall: Reports of hearing performance degradation
FDA Recall date: March 10, 2020
Recall details: Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that… See more

#medicaldevices #recall #santaclarita #california #unitedstates

5   Comments Comment

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