Data Foundry

Medical device recalls 2012

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the… — Class II medical device recall Z-2284-2012

Terminated recall by Steris Corporation, reported 2012-09-05, distributed nationwide. STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain

Recall numberZ-2284-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSteris Corporation, Mentor, OH, United States
Recall initiated2012-08-10
Classified2012-08-28
Reported by FDA2012-09-05
Terminated2013-07-05
DistributedNationwide (US)
Quantity64 units
Reason classeslabeling
Lot numbers1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190

Product

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

Reason for recall

STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

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-2284-2012. 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.