RecallRadar

FDA Device recall Z-0449-2021

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

On 2020-11-25 the FDA classified a Class II recall of Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection by Thomas Scientific, citing the firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0449-2021
ClassificationClass II
Statusongoing
Initiated2020-07-14
Published2020-11-25
Last updated2026-09-13 11:55 UTC
CompanyThomas Scientific
DistributionUS

Product

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

Reason

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

Identifiers

code_info
Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 0622…Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0449-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.