The devices may have a misaligned thickness control bar.
Reason for recall: The devices may have a misaligned thickness control bar. Distribution: Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the distribution and the identification of the domestic consignees. Quantity: 839 units Lot/code info: Lot Code: Model No 00880100100, UDI (01)00889024375901(21)115821, Lot Number 65944745, Serial Number 115821; Model No 00880100100, UDI (01)00889024375901(21)115824, Lot Number 65944745, Serial Number 115824; Model No 00880100100, UDI (01)00889024375901(21)115826, Lot Number 65944745, Serial Number 115826; Model No 00880100100, UDI (01)00889024375901(21)115827, Lot Number 65944745, Serial Number 115827; Model No 00880100100, UDI (01)00889024375901(21)115829, Lot Number 65944745, Serial Number 115829; Model No 00880100100, UDI (01)00889024375901(21)115831, Lot Number 65944745, Serial Number 115831; Model No 00880100100, UDI (01)00889024375901(21)115832, Lot Number 65944745, Serial Number 115832; Model No 00880100100, UDI (01)00889024375901(21)115834, Lot Number 65944745, Serial Number 115834; Model No 00880100100, UDI (01)00889024375901(21)115835, Lot Number 65944745, Serial Number 115835; Model No 00880100100, UDI (01)00889024375901(21)115836, Lot Number 65944745, Serial Number 115836; Model No 00880100100, UDI (01)00889024375901(21)115838, Lot Number 65944745, Serial Number 115838; Model No 00880100100, UDI (01)00889024375901(21)115839, Lot Number 65944748, Serial Number 115839; Model No 00880100100, UDI (01)00889024375901(21)115841, Lot Number 65944748, Serial Number 115841; Model No 00880100100, UDI (01)00889024375901(21)115842, Lot Number 65944748, Serial Number 115842; Model No 00880100100, UDI (01)00889024375901(21)115843, Lot Number 65944748, Serial Number 115843; Model
00880100100, 00889024375901
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.