Class II — Civco Medical Instruments Inc
| Recalling firm | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Registered facility | CIVCO Medical Instruments Co., Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. |
| Product | Civco 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. |
| Quantity | 138 belly boards |
| Distribution | Worldwide 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. |
| Initiated | 2013-10-25 |
| Classified | 2014-01-21 |
| Terminated | 2017-02-02 |
| Recall number | Z-0802-2014 |
| Initiation | Voluntary: 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/
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