Milex Gellhorn Flexible under the following labels: 1) Gellhorn… — Class II medical device recall Z-1152-2021
Terminated recall by CooperSurgical, Inc., reported 2021-03-10, distributed nationwide. The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a sh
| Recall number | Z-1152-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2021-01-21 |
| Classified | 2021-02-26 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2024-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, NZ |
| Lot numbers | 276529, 276637, 283083, 288491, 288492 |
| Model numbers | MXKPGSS2-1/4, MXPGSS2-1/4, MXPGSS2-3/4 |
| Expiration dates | 2025-05-12, 2025-05-14, 2025-05-29, 2025-06-10, 2026-02-12 |
Product
Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)
Reason for recall
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.
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-1152-2021. 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.