Data Foundry

Medical device recalls 2019

Manual Diff Dropper — Class III medical device recall Z-0287-2020

Terminated recall by Biomedical Polymers, Inc., reported 2019-11-13, distributed nationwide. The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid bac

Recall numberZ-0287-2020
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomedical Polymers, Inc., Sterling, MA, United States
Recall initiated2019-09-18
Classified2019-11-05
Reported by FDA2019-11-13
Terminated2020-09-15
DistributedNationwide (US)
Quantity2,052,000
UPC / GTIN / UDI-DI50885380116009
Lot numbers20180709A1C, 20180717A1C
Model numbersCHB4001

Product

Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.

Reason for recall

The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.

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-0287-2020. 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.