FDA Medical Device Recalls (openFDA)
Animas Corporation: Animas IR 1250 Insulin Pump.
- Recall number
- Z-0929-05
- Recalling firm
- Animas Corporation
- Product
- Animas IR 1250 Insulin Pump.
- Status
- Terminated
- Initiated
- 2005-04-11
- Posted
- 2005-06-25
- Terminated
- 2006-01-24
- Reason
- pump failed to respond to keypad button pressess after using the food database feature
- Root cause
- Other
- Action
- The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.
- Quantity
- 2081 units
- Distribution
- The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.
- Lot, serial or model codes
- Model IR1250
- 510(k) numbers
- ["K042873"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3002920072
- Firm city
- West Chester
- Firm state
- PA
- 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