Categories

B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter

For Immediate Release – BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-1000-ml-and-09

 
Categories

Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps

SAN DIEGO – August 7, 2025 – 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.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tandem-diabetes-care-issues-voluntary-medical-device-correction-select-tslim-x2-insulin-pumps

 
Categories

Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings

Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or death

http://www.fda.gov/medical-devices/medical-device-recalls/breathing-system-filters-recall-draeger-removes-safestar-and-twinstar-filters-due-risk-misleading

 
Categories

Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.

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 Ap

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-announces-worldwide-expanded-recall-and-removal-all-speedcontrol-dials-market