Colpo-Pneumo Occluder — Class II medical device recall Z-0098-2019
Terminated recall by CooperSurgical, Inc., reported 2018-10-17, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
| Recall number | Z-0098-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2018-09-04 |
| Classified | 2018-10-11 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2020-05-27 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, CA, CH, CZ, DE, ES, GB, HK, IL, IT, JP, KR, MX, MY, NL, NZ, SG, SI |
| Quantity | 32,538 |
| Reason classes | sterility, packaging |
| Lot numbers | 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247610, 248112, 7609 |
| Model numbers | CPO-6 |
Product
Colpo-Pneumo Occluder, Part CPO-6
Reason for recall
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
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-0098-2019. 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.