Class IIOngoingZ-1984-2026
Immuno-Mycologics, Inc recalls Immy
Neutralization Buffer may contain contaminants
- General Purpose Reagent
- Under Investigation by firm
Immuno-Mycologics, IncOKMay 6, 2026
General Purpose Reagent recalls
The FDA has posted 6 enforcement recalls of general purpose reagent devices since 2025, none of them Class I (most serious). Most recent report: May 6, 2026.
Class II: 6
Who is recalling these devices
Latest recalls
View all 6 in the recall browser →Class IIOngoingZ-0942-2026
Copan Italia recalls 1ml of DTT in liquid phase
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
- General Purpose Reagent
- Under Investigation by firm
Copan ItaliaDec 24, 2025
Class IIOngoingZ-0943-2026
Copan Italia recalls 1ml of DTT in liquid phase
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
- General Purpose Reagent
- Under Investigation by firm
Copan ItaliaDec 24, 2025
Class IIOngoingZ-0773-2026
GET TESTED INTERNATIONAL AB recalls Akkermansia Test
Distribution without premarket approval/clearance.
- General Purpose Reagent
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-1993-2025
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solut…
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
- General Purpose Reagent
- Under Investigation by firm
Diagnostica Stago, Inc…NJJun 25, 2025
Class IIOngoingZ-1834-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
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.…
- General Purpose Reagent
- Storage
Mckesson Medical-Surgi…VAJun 4, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“General Purpose Reagent”). Informational only — verify against the FDA before acting.