Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1152-2021·Announced 2021-03-10

CooperSurgical Recalls Milex Gellhorn Flexible Pessaries Due to Manufacturing Error

CooperSurgical is recalling specific lots of Milex Gellhorn Flexible pessaries because they were manufactured with incorrect stem lengths.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a manufacturing defect (incorrect stem length) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

CooperSurgical, Inc. is recalling 109 units of Milex Gellhorn Flexible pessaries. The affected products were distributed worldwide, including in the United States and specific countries such as New Zealand and the United Kingdom.

The recall was initiated because the affected pessaries were incorrectly manufactured with a long stem (2.170 inches) instead of the required short stem (1.670 or 1.960 inches nominal height). This length discrepancy does not meet the released print dimensions for the product.

The recall includes specific reference numbers and lot numbers identified in recall letters dated January 21, 2021, and September 8, 2021. Consumers and healthcare providers should check their inventory for the specific reference and lot numbers listed in the official recall notice and stop using the affected units.

The recalled product

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…
Manufacturer: CooperSurgical, Inc.
Category: Medical Device — Gynecological Device
Hazard: manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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
Lot 288491- Exp Date May 14
Lot # 288492- Exp Date May 29
Lot 276637- Exp Date February 12
2026

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Same manufacturer · CooperSurgical, Inc.

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