Lower riskMedical device recall · FDA · Published April 9, 2020
CooperSurgical Dilator Set Recall: Compromised Sterile Pouch Risk
CooperSurgical recalls sterile cervical dilator sets with potentially compromised pouch seals. Affected units from specific lot number may pose infection risk if used improperly.
“CooperSurgical Dilator Set Recall: Compromised Sterile Pouch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65456-coopersurgical-dilator-set-recall-compromised-sterile-pouch-risk. Based on FDA recall #Z-2112-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2112-2020%22&limit=1).
CooperSurgical, Inc. recalled one lot of CooperSurgical Dilator/Sound Sets due to a compromised sterile pouch seal, according to the FDA on April 9, 2020.
How to tell if you have it
Brand: CooperSurgical
Product: CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea
Part Number: MX21
Lot Code: 257589
The hazard
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Context
GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since October 6, 2017. Recent similar product recalls include a Covidien EndoStitch Polysorb Loading Unit on April 15, 2026, and a Boston Scientific Intracept Access Instruments recall on April 22, 2026.
How to tell if you have this one
Check for the product name 'CooperSurgical Dilator/Sound Set', lot number 257589, and the model number MX21. The product was made in South Korea and sold as a sterile/EO device.
Brand
CooperSurgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number and model number on the sterile pouch to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 24 states and D.C..
Listed by the agency
Not listed
FDA distribution: “Distribution to North America including the following states: 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Indiana, Iowa, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2112-2020 (April 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2112-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.