CooperSurgical recalls Milex Gellhorn Flexible pessaries with incorrect stem length that may cause improper fit or displacement. Affected models include specific reference numbers and lots.
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.
Take action
Contact the company
📍Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
“CooperSurgical Milex Gellhorn Flexible Pessaries: Incorrect Stem Length Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63360-coopersurgical-milex-gellhorn-flexible-pessaries-incorrect-stem-length-risk. Based on FDA recall #Z-1152-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1152-2021%22&limit=1).
The FDA announced on Jan. 21, 2021, that CooperSurgical, Inc. is recalling Milex Gellhorn Flexible pessaries because they were incorrectly manufactured with a long stem instead of the required short stem. The agency classified this as a Class II recall.
REF MXPGSS2-1/4, Lots 283083 (Exp May 12, 2025), 288491 (Exp May 14, 2025), 288492 (Exp May 29, 2025)
REF MXPGSS2-3/4, Lot 276637 (Exp Feb. 12, 2026)
The hazard
The FDA stated that the affected pessaries have a stem length of 2.170 inches instead of the required 1.670 or 1.960 inches nominal height. This discrepancy does not meet the released print dimensions.
Context
GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since Oct. 6, 2017. Other recent recalls of similar products include INCA Infant Nasal CPAP (Aug. 11, 2026), Endosee System Convenience Kit (June 11, 2025), and K-Systems R65 Trolley (Nov. 15, 2024). Other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device (June 8, 2026), Micro Therapeutics Pipeline Flex Embolization Device (June 25, 2026), and Aesculap MINOP Trocar 150mm (Jan. 15, 2026).
How to tell if you have this one
Check the product label for reference numbers: MXKPGSS2-1/4 (with kit), MXPGSS2-1/4 (without kit), or MXPGSS2-3/4. The recall includes specific production lots and expiration dates listed in the recall letter.
Brand
CooperSurgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for reference numbers on the label: MXKPGSS2-1/4, MXPGSS2-1/4, or MXPGSS2-3/4.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, FL, IL, KS, MA, MI, NC, NY, PA, TN, TX, WA, & Puerto Rico. The countries of New Zealand, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Florida, Illinois, Kansas, Massachusetts, Michigan, New York, North Carolina, Pennsylvania, Puerto Rico, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 2.9 years 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-1152-2021 (January 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1152-2021 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.