Data Foundry

Medical device recalls 2023

COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped… — Class II medical device recall Z-2620-2023

Ongoing recall by Copan Diagnostics Inc, reported 2023-09-27, distributed in CA. Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance

Recall numberZ-2620-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCopan Diagnostics Inc, Murrieta, CA, United States
Recall initiated2023-07-14
Classified2023-09-20
Reported by FDA2023-09-27
DistributedCA
Quantity2,592 units
Lot numbersB104661, B202918, B203404, B203405, B204186, B204187, B204819, B204820, B300133, B300410, B300608, B300647, B300679, B301129, B301133, B301134, B301135
Model numbers2U045S01, 300UL

Product

COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

Reason for recall

Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance

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-2620-2023. 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.