Class IIOngoingZ-1815-2026
3B Medical, Inc. recalls React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
3B Medical, Inc.OHApr 22, 2026
Recalls: Storage
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 39 recalls
Class IIOngoingZ-1184-2026
GOLD STAR DISTRIBUTION INC recalls PREGNANCY TEST 24CT
Potential exposure of rodents and rodent activity in the distribution center.
GOLD STAR DISTRIBUTION…MNFeb 4, 2026
Class IIOngoingZ-1183-2026
GOLD STAR DISTRIBUTION INC recalls Toothbrushes
Potential exposure of rodents and rodent activity in the distribution center.
GOLD STAR DISTRIBUTION…MNFeb 4, 2026
Class IIOngoingZ-1182-2026
GOLD STAR DISTRIBUTION INC recalls Feminine hygiene products
Potential exposure of rodents and rodent activity in the distribution center.
GOLD STAR DISTRIBUTION…MNFeb 4, 2026
Class IIOngoingZ-1181-2026
GOLD STAR DISTRIBUTION INC recalls Condoms
Potential exposure of rodents and rodent activity in the distribution center.
GOLD STAR DISTRIBUTION…MNFeb 4, 2026
Class IIOngoingZ-1180-2026
GOLD STAR DISTRIBUTION INC recalls Bandages and first aid kits: FIRST AID KIT 24/42PC
Potential exposure of rodents and rodent activity in the distribution center.
GOLD STAR DISTRIBUTION…MNFeb 4, 2026
Class IIOngoingZ-2070-2025
HemoCue AB recalls The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201…
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed.…
HemoCue ABJul 9, 2025
Class IIOngoingZ-1855-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
Mckesson Medical-Surgi…VAJun 4, 2025
Class IIOngoingZ-1854-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
Mckesson Medical-Surgi…VAJun 4, 2025
Class IIOngoingZ-1853-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
Mckesson Medical-Surgi…VAJun 4, 2025
Class IIOngoingZ-1852-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
- (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions Free Prostate Specific Antigen Test
- Storage
Mckesson Medical-Surgi…VAJun 4, 2025
Class IIOngoingZ-1851-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
Mckesson Medical-Surgi…VAJun 4, 2025