FDADecember 2, 2024device
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
What to do
FDA enforcement status: Ongoing
Brands named
coloplast manufacturingcoloplast
UPCs
360004012685136000401269813600040127117360004012724736000401273773600040127506360004012761236000401277423600040127872360004012800836000401282683600040128398
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCDaikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury from Fire and Burns2026-06-25
- CPSCKawasaki Motors USA Recalls Model Year 2026 Teryx4 H2 and Teryx5 H2 Recreational Off-Road Vehicles Due to Impact and Injury Hazards2026-06-11
- FDABrand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled...2026-02-19
- FDAHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd2026-02-18
- CPSCWatkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Hazards2026-02-12
- CPSCNorthern Tool + Equipment Recalls Hot Water Pressure Washers Due to Fire Hazard2026-01-29
- FDAAonic Complete His. Dosage: Single serving liquid dietary supplement drink shot, 34 ml (1.1 Fl oz) in plastic bottle, induction sealed closed with plastic lid. Each bottle is a serving intended to be taken orally as a dietary supplement. Sipping unit: two 15 count decorated boxes in a corrugated ...2026-01-15
- FDAAonic Complete Hers. Dosage: Single serving liquid dietary supplement drink shot, 34 ml (1.1 Fl oz) in plastic bottle, induction sealed closed with plastic lid. Each bottle is a serving intended to be taken orally as a dietary supplement. Shipping unit: two 15 count decorated boxes in a corrugate...2026-01-15
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