RegWardenFDA facility compliance records
Recall

Class II — Civco Medical Instruments Co. Inc.

Recalling firmCIVCO Medical Instruments Co., Inc.
Registered facilityCIVCO Medical Instruments Co., Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
ProductCIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Quantity3 units
DistributionUnited States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Initiated2018-07-30
Classified2018-08-29
Terminated2020-09-16
Recall numberZ-2947-2018
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 — Civco Medical Instruments Co. Inc. (Z-2947-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80656/

Not open yet

Alerts for CIVCO Medical Instruments Co., Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.