Summary Company Announcement Date: September 19, 2025 FDA Publish Date: September 22, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device Components May Detach During Procedures Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description ViziShot 2 FLEX (19G) EBUS -TBNA needles Company Announcement CENTER VALLEY, Pa., (September 19,…
Goot Essa Recalls Der Mutterschaf Cheese Because of Possible Health Risk
Summary Company Announcement Date: September 19, 2025 FDA Publish Date: September 25, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with Listeria monocytogenes Company Name: Goot Essa LLC Brand Name: Brand Name(s) Product Description: Product Description Der Mutterschaf Cheese Company Announcement Goot Essa LLC of…
AquaStar (USA) Corp Recalls AquaStar Raw Shrimp Skewers Because of Possible Health Risk
Summary Company Announcement Date: September 23, 2025 FDA Publish Date: September 25, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Potential Foodborne Illness – possible radionuclide (Cesium-137) contamination Company Name: Aquastar Corp Brand Name: Brand Name(s) Product Description: Product Description Shrimp Skewers, Raw Peeled Tail-on Company Announcement September 23,…
Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
This recall involves updating instructions for using 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 following the updated instructions. Affected Product…
Sprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes
Summary Company Announcement Date: September 23, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Potential Metal Contaminant – 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 Sprout Organics…
Lawrence Wholesale LLC Recalls Kroger Bagged Frozen Shrimp and Kroger Frozen Shrimp Products Because of Possible Health Risk
Summary Company Announcement Date: September 23, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination. Company Name: LAWRENCE WHOLESALE LLC Brand Name: Brand Name(s) Product Description: Product Description Frozen shrimp Company Announcement Lawrence Wholesale LLC of Vernon, CA…
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
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 Name: ViziShot 2 FLEX (19G) Unique Device Identifier (UDI): 00821925043060 Lot Numbers: Full list…
Lee K of NY Issue Allergy Alert on Undeclared Allergen (Milk and Shrimp) in “Stewed Aged Kimchi w/Mackerel”
Summary Company Announcement Date: September 08, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Milk and Shrimp Company Name: Lee K of NY INC Brand Name: Brand Name(s) Product Description: Product Description Stewed Aged Kimchi w/ Mackerel Company Announcement…
Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
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 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 Abiomed has issued a letter…
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
Catalog Catalog# Description UDI-DI 1000911 t:slim X2 GS, Replacement, Refurbished 00853052007318 1003808 t:slim X2 GS Classic, Replacement, Refurbished 00853052007981 1004219 t:slim X2, Basal-IQ, mg/dl 00853052007998 1004484 Pump, t:slim X2, Clinical Use Only N/A 1005611 Pump, t:slim X2, Control-IQ, mmol/L 00850006613304 1005613 Pump, t:slim X2, Control-IQ, mmol/L, Refurbished Replacement 00850006613311 1005615 Pump, t:slim X2, Control-IQ, mg/dl…