FDA Medical Device Recalls (openFDA)
Hawaii Medical LLC: NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,000 (10 boxes of 100)
- Recall number
- Z-0926-2007
- Recalling firm
- Hawaii Medical LLC
- Product
- NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,000 (10 boxes of 100)
- Status
- Terminated
- Initiated
- 2007-05-11
- Posted
- 2007-06-09
- Terminated
- 2008-07-22
- Reason
- Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient
- Root cause
- Other
- Action
- Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.
- Quantity
- 286,376 units
- Distribution
- Nationwide
- Lot, serial or model codes
- M073010, M085019, M088037, M094012, M106010, M107016, M116013, M122004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 3003827293
- Firm city
- Pembroke
- Firm state
- MA
- 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