Class IIOngoingZ-0383-2026
DAYE (ANNE'S DAY LTD) recalls 9 Coated Regular and 9 Coated Super Tampons
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)Nov 5, 2025
Recalls: No Marketing Application
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 205–216 of 228 recalls
Class IIOngoingZ-0382-2026
DAYE (ANNE'S DAY LTD) recalls 18 Coated Super Tampons
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)Nov 5, 2025
Class IIOngoingZ-0381-2026
DAYE (ANNE'S DAY LTD) recalls 18 Coated Regular Tampons
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)Nov 5, 2025
Class IIOngoingZ-0380-2026
DAYE (ANNE'S DAY LTD) recalls 9 Coated Regular Tampons and 9 Nude Regular Tampons
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)Nov 5, 2025
Class IIOngoingZ-0379-2026
DAYE (ANNE'S DAY LTD) recalls 9 Coated Super Tampons and 9 Nude Super Tampons
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)Nov 5, 2025
Class IIOngoingZ-0107-2026
Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples.…
Inpeco S.A.Oct 15, 2025
Class IIOngoingZ-0106-2026
Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples.…
Inpeco S.A.Oct 15, 2025
Class IIOngoingZ-2585-2025
Abbott Point Of Care Inc. recalls i-STAT EG6+ cartridge. List Number: 03P77-25.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care I…NJSep 24, 2025
Class IIOngoingZ-2584-2025
Abbott Point Of Care Inc. recalls i-STAT EG7+ cartridge. List Number: 03P76-25.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care I…NJSep 24, 2025
Class IIOngoingZ-2583-2025
Abbott Point Of Care Inc. recalls i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care I…NJSep 24, 2025
Class IIOngoingZ-2582-2025
Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Abbott Point Of Care I…NJSep 24, 2025
Class IIOngoingZ-2552-2025
Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay
Measles IgM Test Kit lacks premarket approval or clearance.
Quest International, I…FLSep 17, 2025