Data Foundry

Medical device recalls 2018

Stanbio AC power adapter for the HemoPoint H2 meter — Class II medical device recall Z-2926-2018

Terminated recall by Stanbio Laboratory, LP, reported 2018-09-05, distributed nationwide. The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing l

Recall numberZ-2926-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStanbio Laboratory, LP, Boerne, TX, United States
Recall initiated2018-02-08
Classified2018-08-24
Reported by FDA2018-09-05
Terminated2020-09-04
DistributedNationwide (US)
Countries outside the USBO, MX, MY, PH, PY
Quantity2,804 devices
Reason classespackaging, device malfunction
Model numbersG3000

Product

Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

Reason for recall

The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

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-2926-2018. 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.