Data Foundry

Medical device recalls 2019

BD Microtainer SST- Amber Part/Catalog Number: 365978 — Class II medical device recall Z-0058-2020

Terminated recall by Becton Dickinson & Company, reported 2019-10-16, distributed nationwide. Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and impro

Recall numberZ-0058-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Company, Franklin Lakes, NJ, United States
Recall initiated2019-05-13
Classified2019-10-07
Reported by FDA2019-10-16
Terminated2020-08-06
DistributedNationwide (US)
UPC / GTIN / UDI-DI30382903659785, 30382903659792, 50382903659789, 50382903659796
Model numbers365978

Product

BD Microtainer SST- Amber Part/Catalog Number: 365978

Reason for recall

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

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-0058-2020. 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.