Potential for overpressure alerts.
Reason for recall: Potential for overpressure alerts. Distribution: Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND Quantity: 891 packs (5,346 eaches) Lot/code info: Catalog Number: iASB12-120. UDI-DI: 10845854045725. Lot Numbers: 202507314, 202506194, 202510024, 202501165, 202504034, 202408225, 202411264. *OUS added 06/10/2026 expansion: 202510024, 202507314, 202504034, 202501165, 202411264, 202408225, 202506194. Manufactured from 14 June 2024 to 12 January 2026.
10845854045725
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.