CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm recallZ-1239-2015 · CooperSurgical, Inc. · initiated Feb 9, 2015
Class II Terminated All recalls posted in March 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect size printed on the Milex Pessary Kit packaging label
FDA root cause category: Error in labeling
What the company is doing
CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Questions contact CooperSurgical 203.601.5200.
Recall details
- Recall number
- Z-1239-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 9, 2015
- Posted by the FDA
- Mar 3, 2015
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 95 units
- Product code
- HHW
- FDA submissions
- K904026
- Distribution
- Nationwide Distribution
Product description
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Code information (models, lots, serial numbers)
Lot numbers: 144351, 142789
Other devices under the same FDA submission
1 device cleared under K904026 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MILEX MXFIT0023Coopersurgical, Inc. · Pessary, Vaginal1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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