Thio Med w/o Ind — Class II medical device recall Z-1404-2019
Terminated recall by Remel Inc, reported 2019-05-29, distributed nationwide. Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days aft
| Recall number | Z-1404-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2019-04-17 |
| Classified | 2019-05-22 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 282 units |
| Lot numbers | 307916, 311677, 337081, 347391, 359857, 366062, 381201, 390570, 396653, 417781, 423518 |
Product
Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Reason for recall
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
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-1404-2019. 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.