RegWardenFDA facility compliance records
Recall

Class II — Civco Medical Instruments Inc

Recalling firmCIVCO Medical Instruments Co., Inc.
Registered facilityCIVCO Medical Instruments Co., Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonScales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
ProductCivco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Quantity138 belly boards
DistributionWorldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
Initiated2013-10-25
Classified2014-01-21
Terminated2017-02-02
Recall numberZ-0802-2014
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 — Civco Medical Instruments Inc (Z-0802-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66591/

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.