FDA Medical Device Recalls (openFDA)
Hospira, Inc.: EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
- Recall number
- Z-0126-2011
- Recalling firm
- Hospira, Inc.
- Product
- EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
- Status
- Terminated
- Initiated
- 2010-07-26
- Posted
- 2010-10-22
- Terminated
- 2014-02-25
- Reason
- The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin.
- Root cause
- Other
- Action
- Hospira issued an Urgent Device Field Correction letter dated July 23, 2010 to consignees, providing details of the potential issue and the associated patient risk. Hospira is finalizing software enhancements which will resolve this situation within the next 90 days ,and will contact each consignee when it is available to be downloaded from the Hospira website. The notification letter also included a clinical bulletin, outlining mitigation instructions for clinicians to use until the software enhancement is available. Consignees were requested to complete and return an attached Reply Form by fax. Customers can contact the Hospira EndoTool support line at 1-877-349-4582 for clinical inquiries about this recall.
- Quantity
- 97 units total (96 version 7.2.1800.3 and 1 version 7.2.1825.5)
- Distribution
- Nationwide Distribution in states of CA, FL, IL, IN, KY, KS, MI, MO, MT, NC, NJ, NM, NV, OH, SC, SD, TN, TX, VA, WA, and WY.
- Lot, serial or model codes
- Software Version 7.2.1800.3 and 7.2.1825.5
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DNN
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- 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