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Safety Reports: Medical Devices

Updated: March 13, 2026 12:15 PM

Real Time Reports

Recall notice

Omnipod Alternate Controller Insulin Pump recalled for Insulin Leakage Issue, USA

3 weeks ago •source fda.gov • details

Insulet Corporation (NASDAQ: PODD) ("Insulet" or the "Company") today initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific identified lots distributed in the United States. Insulet has received… See more

#medicaldevices #unitedstates #sugar

Recalls Omnipod Alternate Controller Insulin Pump recalled for Insulin Leakage Issue Insulet Corporation (NA... photo #1

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Recall notice

ViziShot 2 FLEX (19G) EBUS -TBNA needles recalled due to Defect, USA

2 months ago •source fda.gov • details

Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles ("ViziShot 2 FLEX") after receiving and investigating complaints of device components ejecting or detaching during procedures. The complaints included adverse event reports of patient injury… See more

#recall #medicaldevices #unitedstates

Recalls ViziShot 2 FLEX (19G) EBUS -TBNA needles recalled due to Defect Olympus Corporation has announced th... photo #1

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Recall notice

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

2 months 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

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Recall notice

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

3 months 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

5 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

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Recall notice

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

5 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

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Recall notice

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

6 months ago •source fda.gov • details

Update January 16th, 2026:
Olympus has expanded its voluntary global removal of ViziShot 2 FLEX (19G) EBUS-TBNA needles to include all lots, replacing the earlier August 2025 action that applied only to specific lots. The expansion follows further investigation into complaints involving device components ejecting or detaching… See more

#medicaldevices #recall #unitedstates

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

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Recall notice

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

6 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

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Recall notice

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

7 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

7 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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Safety Reports: Medical Devices

Real Time Reports

Omnipod Alternate Controller Insulin Pump recalled for Insulin Leakage Issue, USA

ViziShot 2 FLEX (19G) EBUS -TBNA needles recalled due to Defect, USA

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

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

Olympus Medical Device recalled due to Endobronchial Combustion, USA

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

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

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

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

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

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