Class II — Thomas Scientific
| Recalling firm | Thomas Scientific, LLC |
|---|---|
| Registered facility | Thomas Scientific, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. |
| Product | Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection. |
| Quantity | 115,800 cs (100 vials/cs) |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| Initiated | 2020-07-14 |
| Classified | 2020-11-13 |
| Recall number | Z-0449-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Thomas Scientific (Z-0449-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86607/
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