FDA Device recall Z-2112-2020
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 by Coopersurgical, citing the seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2112-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-09 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Coopersurgical |
| Distribution | 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 |
Product
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Reason
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Identifiers
| code_info | Lot # 257589 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2112-2020%22
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