Data Foundry

Medical device recalls 2020

Wuxi Nest — Class II medical device recall Z-0449-2021

Ongoing recall by Thomas Scientific, reported 2020-11-25, distributed nationwide. The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approva

Recall numberZ-0449-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmThomas Scientific, Swedesboro, NJ, United States
Recall initiated2020-07-14
Classified2020-11-13
Reported by FDA2020-11-25
DistributedNationwide (US)
Lot numbers051820D01, 052120E01, 052220MB1, 052720D02, 060120D01, 060620MB1, 060620MB2, 061420MB2, 061520MA1, 061720MB1, 061920E01, 062120MB1, 062220D02, 062220MB2
Model numbers202017, 202018, 202115, 202117

Product

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

Reason for recall

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

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-0449-2021. 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.