CLASS III Device recall · Reported 3 Apr 2013 · FDA Enforcement Report

Gellhorn Flexible Pessary 3" Milex recalled by Cooper Surgical

Cooper Surgical is recalling Gellhorn Flexible Pessary 3" Milex, distributed nationwide in the US. The recall was initiated on 26 Feb 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Number:117568

Quantity recalled175 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1010-2013
FDA event ID: 64531
Recalling firm: Cooper Surgical, Trumbull, CT
Classification: Class III
Status: Terminated
Recall initiated: 26 Feb 2013
FDA classified: 27 Mar 2013
Reported: 3 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

26 Feb 2013	Recall initiated by company
27 Mar 2013	Classified by FDA	+29 days
3 Apr 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Product as listed by the FDA

Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Where it was distributed

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Nationwide

Questions about this recall

Why was it recalled?

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Which lots are affected?

Lot Number:117568

Where was it sold?

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 64531

Reported	Class	Recall	Company	Reason	Where
3 Apr 2013	CLASS III	Incontinence Dish w/ Support Pessary #0 Milex recalled	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Cube Pessary w/Drainage Holes #0"1" Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Incontinence Dish Folding Pessary #0 Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Cube Pessary 1 5/8"" Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Incontinence Dish Folding Pessary #0 Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Incontinence Ring Flexible Pessary #4, 2 3/4" Milex recalled	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Gellhorn Flexible Pessary -2 3/4" Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013	CLASS III	Incontinence Dish w/ Support Pessary #5 Milex recalled	Cooper Surgical	Labeling Errors	Nationwide

More recalls from Cooper Surgical

All 13

Reported	Class	Recall	Company	Reason	Where
10 Apr 2013Device	CLASS II	Leep Redikit Product No. a Loop Electrosurgical Excision recalled	Cooper Surgical	Other	Nationwide
3 Apr 2013Device	CLASS III	Incontinence Dish w/ Support Pessary #5 Milex recalled	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013Device	CLASS III	Gellhorn Flexible Pessary -2 3/4" Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013Device	CLASS III	Incontinence Ring Flexible Pessary #4, 2 3/4" Milex recalled	Cooper Surgical	Labeling Errors	Nationwide
3 Apr 2013Device	CLASS III	Incontinence Dish Folding Pessary #0 Milex recalled by Cooper Surgical	Cooper Surgical	Labeling Errors	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide