FDA Device recall Z-1152-2021
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…
- FDA Device
- Class II
- terminated
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class II recall of 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… by Coopersurgical, citing 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 disc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1152-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-21 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | US |
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
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.
Identifiers
| code_info | Recall letter dated 1/21/2021: 1) With Kit: REF #: MXKPGSS2-1/4, Lot #: 276529- Exp Date June 10, 2025, 2) Without K…Recall letter dated 1/21/2021: 1) With Kit: REF #: MXKPGSS2-1/4, Lot #: 276529- Exp Date June 10, 2025, 2) Without Kit: REF #: MXPGSS2-1/4, Lot #: 283083- Exp Date May 12, 2025; Lot 288491- Exp Date May 14, 2025; Lot # 288492- Exp Date May 29, 2025. Recall letter dated 9/8/2021 included one additional lot: 3) REF # MXPGSS2-3/4, Lot 276637- Exp Date February 12, 2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1152-2021%22
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