Lingen SAMPLE Disposable Virus Sampling Kit pack — Class II medical device recall Z-2067-2021
Terminated recall by Mercedes Medical, Inc., reported 2021-07-21, distributed nationwide. No 510(k) clearance
| Recall number | Z-2067-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mercedes Medical, Inc., Lakewood Ranch, FL, United States |
| Recall initiated | 2021-06-10 |
| Classified | 2021-07-12 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, MX |
| Reason classes | unapproved product |
| Model numbers | MTM-04 |
Product
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
Reason for recall
No 510(k) clearance
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-2067-2021. 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.