Agency classClass IIIOur severity:Low FDA (Devices)·Z-0253-2016·Announced 2015-11-18

CooperSurgical Recalls MILEX Pessary Kits Due to Incorrect Packaging Labels

CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging labeling error where the inner product is correctly marked, fitting the criteria for a Low severity score.

Plain-English summary

CooperSurgical, Inc. is recalling 144 units of the MILEX PESSARY KIT (Model Numbers: MXPES00, MXKPES00, MXKPREG03, MXKPGSK07). The recall is due to incorrect size prints on the product packaging. While the pessary pouch inside is marked with the correct size, the incorrect label on the outer packaging does not meet the required release specification.

The affected products were distributed worldwide, including nationwide in the United States (specifically in AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI, and WV) and in France and Vietnam. Specific lot numbers involved include 139411, 157299, 180533, 125143, 142853, 153096, 157364, and 160432.

The MILEX SILICONE PESSARY is used to manage gynecologic issues, including pelvic support defects and stress urinary incontinence. Consumers should check their packaging for the affected model numbers and lot numbers listed above. If the packaging displays incorrect size information, they should contact CooperSurgical for instructions on how to proceed.

The recalled product

Product: MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
Manufacturer: CooperSurgical, Inc.
Category: Medical Device — Gynecological Devices
Hazard: mis-labeling
Affected units: 144

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 (5)

MXPES00: Lot139411
157299
180533 MXKPES00: Lot 125143
142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364
160432

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Same manufacturer · CooperSurgical, Inc.

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