Data Foundry

Medical device recalls 2013

Blanketrol III Data Export Software Version 1 — Class II medical device recall Z-0443-2014

Terminated recall by Cincinnati Sub-Zero Products Inc, reported 2013-12-11, distributed in AK, CO, FL, MA, MI, NC. During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was dis

Recall numberZ-0443-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCincinnati Sub-Zero Products Inc, Cincinnati, OH, United States
Recall initiated2013-05-15
Classified2013-12-04
Reported by FDA2013-12-11
Terminated2014-05-13
DistributedAK, CO, FL, MA, MI, NC
Countries outside the USCA, DE, GB
Quantity12 units
Reason classessoftware
Lot numbers00554
Model numbers86127, USB-127

Product

Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.

Reason for recall

During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0443-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.