Z-1152-2021Class II

Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF...

Name: Z-1152-2021 Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF...
Creator: CooperSurgical, Inc.
Published: 2021-01-21
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2021-01-21 / Terminated / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a 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) Gellhorn Flexible... on 2021-01-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1152-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-21
Posted: 2021-02-26
Terminated: 2024-01-03
Recalling firm: CooperSurgical, Inc.
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)
Product code: HHW Pessary, Vaginal
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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 01/21/2021, CooperSurgical issued Urgent Medical Device Recall notices to customers via certified mail. On 9/08/2021, CooperSurgical expanded the recall adding an additional lot and notified customers via courier service. Customers were advised to: - Discontinue use of and isolate all products subject to the recall. - Complete the Acknowledgement and Receipt Form, and return via email to [email protected] or fax to 203-601-9870. - Once the Acknowledgement Form is received, Cooper Surgical will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same Form to indicate that and return it to CooperSurgical. Customers with questions, please call 203-601-5200 ext. 3300.
Quantity in commerce: 109 units (Domestic: 60 units, Foreign: 49 units)
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1152-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1152-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-02-26

Product code HHW

K904774Class IIInglat-O-BallMilex Products, Inc. / cleared 1990-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)