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insulin-pump-correction:-tandem-diabetes-care-issues-correction-for-certain-t:slim-x2-insulin-pumps-due-to-risk-for-faulty-speaker-wiring-that-may-cause-malfunction-and-stop-insulin-delivery FDA
  • September 14, 2025

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery

t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that…
bd-provides-update-on-voluntary-recall-of-certain-bd-alaris-pump-infusion-sets FDA
  • September 14, 2025

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company,…
update-on-alert:-defibrillation-lead-issue-from-boston-scientific FDA
  • September 11, 2025

Update on Alert: Defibrillation Lead Issue from Boston Scientific

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
continuous-glucose-monitor-apps-correction:-dexcom,-inc.-issues-correction-for-g7-apps-and-one+-apps-due-to-a-software-design-error-that-does-not-alert-users-of-unexpected-sensor-failure FDA
  • September 11, 2025

Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and…
ventilator-recall:-philips-respironics-removes-certain-dreamstation-devices-due-to-programming-errors-that-can-result-in-failed-therapy-modes FDA
  • September 11, 2025

Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.
2024-safety-communications FDA
  • September 10, 2025

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications
one-frozen,-llc-voluntarily-recalls-good-&-gather-southwest-style-burrito-bowl-blend,-frozen,-12oz-bags-due-to-undeclared-shrimp-allergen FDA
  • September 10, 2025

One Frozen, LLC Voluntarily Recalls Good & Gather™ Southwest Style Burrito Bowl Blend, Frozen, 12oz Bags Due to Undeclared Shrimp Allergen

One Frozen, LLC of Rochester, NY, is voluntarily recalling certain lots of Good & Gather™ Southwest-Style Burrito Bowl Blend (frozen,…
chetak-llc-group-expands-voluntary-product-recall-to-include-additional-frozen-vegetable-and-fruit-products-due-to-possible-health-risk FDA
  • September 10, 2025

Chetak LLC Group Expands Voluntary Product Recall to Include Additional Frozen Vegetable and Fruit Products Due to Possible Health Risk

Collectively (“Chetak”) is expanding its voluntary recall, initiated July 16, 2025, to include several lots of Deep-branded frozen vegetables and…
gina-marie-bakery-of-waterbury-issues-recall-of-cookies-due-to-undeclared-almonds,-sesame-and-food-dyes FDA
  • September 10, 2025

Gina Marie Bakery of Waterbury Issues Recall of Cookies Due to Undeclared Almonds, Sesame and Food Dyes

Gina Marie Bakery of Waterbury, CT is recalling 1lb and 2 lb packages of the above-mentioned cookies because they contain…
gooder-foods-issues-allergy-alert-on-–-undeclared-milk-and-cashews-in-goodles-vegan-is-believin’-–-plant-based-white-cheddar-with-spirals-and-goodles-here-comes-truffle-–-creamy-truffle-flavored-cheddar-and-shells FDA
  • September 10, 2025

Gooder Foods Issues Allergy Alert On – Undeclared Milk and Cashews in Goodles Vegan is Believin’ – Plant Based White Cheddar with Spirals and Goodles Here Comes Truffle – Creamy Truffle Flavored Cheddar and Shells

FOR IMMEDIATE RELEASE — Santa Cruz, CA, September 10, 2025 — Gooder Foods, Inc. is recalling 5 lots of Vegan…