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.
CooperSurgical is recalling Milex Gellhorn Flexible pessaries that were manufactured with a longer stem than intended. This could lead to improper fit or displacement during use, potentially causing discomfort or injury.
The pessaries were made with a stem length of 2.170 inches instead of the required short stem (1.670 or 1.960 inches). This discrepancy may cause the pessary to shift or become misaligned, leading to discomfort or potential displacement.
Women who use Milex Gellhorn Flexible pessaries for menstrual health are most at risk. The recall affects specific model numbers and production lots.
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.
Look for reference numbers on the label: MXKPGSS2-1/4, MXPGSS2-1/4, or MXPGSS2-3/4.
The affected pessaries were manufactured with a stem length of 2.170 inches instead of the required short stem (1.670 or 1.960 inches).
The affected models include Milex Gellhorn Flexible pessaries with reference numbers MXKPGSS2-1/4 (with kit), MXPGSS2-1/4 (without kit), and MXPGSS2-3/4.
The recall does not specify a remedy, so contact CooperSurgical directly for guidance on next steps.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1152-2021 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1152-2021 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
