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Recall

Class II — Ecolab Inc

Recalling firmEcolab Inc
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonCertain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
ProductVital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
Quantity6,000 individual units
DistributionWorldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.
Initiated2013-07-02
Classified2014-02-10
Terminated2014-05-14
Recall numberZ-0948-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ecolab Inc (Z-0948-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65667/

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