This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Medline has issued a…
Sprout Organics Voluntarily Recalls One Lot of Sweet Potato Apple and Spinach Due to Possible Health Risk
Summary Company Announcement Date: September 16, 2025 FDA Publish Date: September 16, 2025 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Product may contain elevated levels of lead Company Name: Sprout Organics Brand Name: Brand Name(s) Sprout Organics Product Description: Product Description Sweet Potato Apple and Spinach, 3.5-ounce pouch Company Announcement…
Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Micro Joystick R-net Multi…
BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
Summary Company Announcement Date: September 12, 2025 FDA Publish Date: September 15, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Pump performance variations compared to the performance described in the user manual could impact infusion delivery Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description BD Alaris Pump Module model…
Update on Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you…
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
This recall involves correcting certain devices through a software update and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names:…
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Description Model Number UDI-DI DreamStation Auto CPAP UDSX500S11F 00606959423314 DreamStation Auto BiPAP UDSX700S11F 00606959423338…
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
Summary Company Announcement Date: September 10, 2025 FDA Publish Date: September 11, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk and cashews Company Name: Gooder Foods, Inc Brand Name: Brand Name(s) Product Description: Product Description Flavored pasta Company Announcement FOR IMMEDIATE RELEASE — Santa Cruz, CA, September 10,…
Gina Marie Bakery of Waterbury Issues Recall of Cookies Due to Undeclared Almonds, Sesame and Food Dyes
Summary Company Announcement Date: September 10, 2025 FDA Publish Date: September 10, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared almonds, sesame, Red 40, Red 3, Blue 1, Yellow 5, Red 40, Yellow 6 Company Name: Gina Marie Bakery Brand Name: Brand Name(s) Product Description: Product Description Company Announcement…
One Frozen, LLC Voluntarily Recalls Good & Gather™ Southwest Style Burrito Bowl Blend, Frozen, 12oz Bags Due to Undeclared Shrimp Allergen
Summary Company Announcement Date: September 10, 2025 FDA Publish Date: September 10, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared shrimp (shellfish) Company Name: One Frozen, LLC Brand Name: Brand Name(s) Good & Gather Product Description: Product Description Frozen Burrito Bowl Company Announcement One Frozen, LLC of Rochester, NY,…