FDA Medical Device Recalls (openFDA)
Animas Corporation: Animas ezManager Max Diabetes Management System version 2.0.9
- Recall number
- Z-0481-2010
- Recalling firm
- Animas Corporation
- Product
- Animas ezManager Max Diabetes Management System version 2.0.9
- Status
- Terminated
- Initiated
- 2009-11-02
- Posted
- 2009-12-03
- Terminated
- 2010-10-27
- Reason
- Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
- Root cause
- Software design
- Action
- Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.
- Quantity
- 20,648 units
- Distribution
- Nationwide distribution, and Canada, Cayman Islands, and Denmark.
- Lot, serial or model codes
- version 2.0.9
- 510(k) numbers
- ["K080587"]
- PMA numbers
- not on file
- Product code
- MRZ
- 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