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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

FreeStyle Libre 3 and 3 Plus Glucose Monitoring Sensors recalled due to Incorrect Readings, USA

2 days ago •source fda.gov • details

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings. This action involves approximately 3 million Libre 3 and Libre 3 Plus… See more

#medicaldevices #unitedstates

Recalls FreeStyle Libre 3 and 3 Plus Glucose Monitoring Sensors recalled due to Incorrect Readings Abbott ha... photo #1
  Comments Comment

Recall notice

Olympus Single use ligating device recalled due to PolyLoop Device fail to detach, USA

4 weeks ago •source fda.gov • details

Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device ("Polyloop") following identification of a potential safety issue. The affected product is distributed nationwide in the United States.

The Polyloop device is designed for use with Olympus endoscopes to deliver a nylon… See more

#medicaldevices #unitedstates

Recalls Olympus Single use ligating device recalled due to PolyLoop Device fail to detach Olympus Corporatio... photo #1
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Recall notice

Olympus Medical Device recalled due to Endobronchial Combustion, USA

2 months ago •source fda.gov • details

Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree. The devices were distributed across the United… See more

#medicaldevices #unitedstates

Recalls Olympus Medical Device recalled due to Endobronchial Combustion Olympus Corporation has announced a... photo #1
  Comments Comment

Recall notice

TRUE METRIX Blood Glucose Meters - recalled due to defective LCD displays, USA

3 months ago •source fda.gov • details

Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States.

The company has determined that 601 TRUE METRIX® Meters, lot number… See more

#medicaldevices #unitedstates

Recalls TRUE METRIX Blood Glucose Meters recalled due to defective LCD displays Trividia Health, Inc., annou... photo #1
  Comments Comment

Recall notice

ViziShot 2 FLEX (19G) EBUS -TBNA needles recalled due to Device Components May Detach During Procedures, USA

3 months ago •source fda.gov • details

Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures.

The ViziShot 2 FLEX is protected by a hypotube and… See more

#medicaldevices #recall #unitedstates

Recalls ViziShot 2 FLEX (19G) EBUS -TBNA needles recalled due to Device Components May Detach During Procedu... photo #1
  Comments Comment

Recall notice

BD Alaris Pump Module recalled due to Pump Performance not as per Manual, USA

4 months ago •source fda.gov • details

BD (Becton, Dickinson and Company) a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performance, under certain use cases, for the BD Alaris™… See more

#medicaldevices #unitedstates

Recalls BD Alaris Pump Module recalled due to Pump Performance not as per Manual BD (Becton, Dickinson and C... photo #1
  Comments Comment

Recall notice

Max Mobility/Permobil Speed Control Dial Component recalled due to Safety Concerns, USA

5 months ago •source fda.gov • details

Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This voluntary action applies to all SpeedControl Dials manufactured and distributed between the dates of April 25, 2022 to… See more

#medicaldevices #recall #unitedstates

Recalls Max Mobility/Permobil Speed Control Dial Component recalled due to Safety Concerns Max Mobility/Perm... photo #1
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Recall notice

t:slim X2 Insulin Pumps recalled due to Device Malfunction, USA

5 months ago •source fda.gov • details

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. There have been 700 confirmed adverse events, defined as a… See more

#medicaldevices #recall #unitedstates

Recalls t:slim X2 Insulin Pumps recalled due to Device Malfunction Tandem Diabetes Care, Inc. (Nasdaq: TNDM)... photo #1
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Recall notice

Newport™ HT70 variant ventilators and service parts recalled due to Potential Defect, USA

7 months ago •source fda.gov • details

Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall. With this recall, Medtronic is advising the discontinuation of… See more

#medicaldevices #recall #unitedstates

Recalls Newport™ HT70 variant ventilators and service parts recalled due to Potential Defect Medtronic issue... photo #1
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Recall notice

####072 Aspiration System recalled due to Distal Tip Design outside scope of 510k clearance####, USA

8 months ago •source fda.gov • details

The U.S. Food and Drug Administration ("FDA" or "the agency"), classified Q'Apel Medical, Inc.'s ("Q'Apel" or "the company") voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name "Hippo", which includes "Cheetah"; collectively, the "product") as Class I. The product was… See more

#medicaldevices #unitedstates

Recalls 072 Aspiration System recalled due to Distal Tip Design outside scope of 510k clearance The U.S. Foo... photo #1
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