Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081… — Class III medical device recall Z-2212-2017
Terminated recall by Acumedia Manufacturers, Inc., reported 2017-06-07, distributed in IL. Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿
| Recall number | Z-2212-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumedia Manufacturers, Inc., Lansing, MI, United States |
| Recall initiated | 2016-08-08 |
| Classified | 2017-06-01 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-06-02 |
| Distributed | IL |
| Quantity | 10 units |
| Reason classes | labeling |
| Lot numbers | 107632A, 108367APN, 91081C |
Product
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Reason for recall
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2212-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.