FDA Medical Device Recalls (openFDA)
Stanbio Laboratory, LP: 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.
- Recall number
- Z-2926-2018
- Recalling firm
- Stanbio Laboratory, LP
- 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.
- Status
- Terminated
- Initiated
- 2018-02-08
- Posted
- not on file
- Terminated
- 2020-09-04
- Reason
- The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
- Root cause
- Nonconforming Material/Component
- Action
- The recall was initiated via letter dated 2/7/2018 by first class mail letter on 2/8/2018 instructing the consignee to stop using the adapter if it is affected and it will be replaced.
- Quantity
- 2,804 devices
- Distribution
- 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.
- Lot, serial or model codes
- Serial number range of affected power adapters: 41800001-41804000
- 510(k) numbers
- ["K081719"]
- PMA numbers
- not on file
- Product code
- GKR
- Firm FEI
- 1616487
- Firm city
- Boerne
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28