openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
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.
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
Code information
Serial number range of affected power adapters: 41800001-41804000
Distribution pattern
Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.