CooperSurgical Dilator/Sound Set — Class II medical device recall Z-2112-2020
Terminated recall by CooperSurgical, Inc., reported 2020-06-03, distributed in AZ, CA, CT, DC, DE, FL, GA, IA…. The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
| Recall number | Z-2112-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2020-04-09 |
| Classified | 2020-05-22 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2021-05-11 |
| Distributed | AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI |
| Reason classes | sterility, packaging |
| Lot numbers | 257589 |
Product
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Reason for recall
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
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-2112-2020. 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.