FDA Medical Device Recalls (openFDA)
Lifescan Inc: OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels
- Recall number
- Z-2835-2011
- Recalling firm
- Lifescan Inc
- Product
- OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels
- Status
- Terminated
- Initiated
- 2011-05-27
- Posted
- 2011-07-15
- Terminated
- 2012-01-05
- Reason
- Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
- Root cause
- Other
- Action
- Lifescan sent an Urgent Medical Device Correction letter dated May 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told that no action on their part is needed and were asked not to return any of the affected product. Customers were instructed to continue to distribute the product. Healthcare professionals and pharmacies were asked to share the information with their patients who use the OneTouch Delica Lancing Device. Patients with questions should contact Customer Care Line at 1-800-574-6138. For questions regarding this recall call 1-800-600-7226.
- Quantity
- 1,032,515 in US
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Lot, serial or model codes
- Model Number 022-137-01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- F
- 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