Cooper Surgical recalls Milex Pessary products manufactured between June 2021 and August 2021 due to potential temperature exposure affecting product effectiveness. Consumers should check product catalog numbers and dates.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Cooper Surgical is recalling Milex Pessary products made between June 1, 2021 and September 30, 2021 because they may have been exposed to higher temperatures during shipping, which could reduce their effectiveness. This recall affects medical devices used for pelvic floor support.
The products may have been exposed to higher temperatures during shipping from June 2021 to August 2021, which could reduce their effectiveness. This temperature exposure might occur if the products were stored or transported in conditions that are too warm for proper function.
Medical professionals and patients using Cooper Surgical's Milex Pessary products with catalog number MXPCON06 purchased between June 1, 2021 and September 30, 2021 are affected. Patients using these devices for pelvic floor support are most at risk if the product's effectiveness is reduced.
Check for catalog number MXPCON06 on the product label. Products were sold between June 1, 2021 and September 30, 2021. The product name is Milex Pessary, Ring Milex Incont Flexible SZ6 1 3/4 inch.
Look for catalog number MXPCON06 on the product label to confirm if it is recalled.
The products may have been exposed to higher temperatures during shipping from June 2021 to August 2021, which could reduce their effectiveness.
Check the product label for catalog number MXPCON06. If it matches, contact Cooper Surgical for further instructions.
The recall is due to potential reduced effectiveness from temperature exposure, not immediate safety risks like injury or illness.
We’ve drafted a message you can send Cooper Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2022 — Cooper Surgical Cooper Surgical Hello, I own a Cooper Surgical that is covered by recall Z-1631-2022 from Cooper Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
