FDA Medical Device Recalls (openFDA)
Lifescan Inc: LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
- Recall number
- Z-0271-06
- Recalling firm
- Lifescan Inc
- Product
- LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
- Status
- Terminated
- Initiated
- 2005-10-11
- Posted
- 2005-12-08
- Terminated
- 2006-11-21
- Reason
- In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
- Root cause
- Other
- Action
- On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
- Quantity
- 1123 boxes
- Distribution
- Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada.
- Lot, serial or model codes
- Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395. Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 2939301
- Firm city
- Milpitas
- Firm state
- CA
- 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