FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
- Recall number
- Z-1239-2015
- Recalling firm
- CooperSurgical, Inc.
- Product
- CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
- Status
- Terminated
- Initiated
- 2015-02-09
- Posted
- 2015-03-03
- Terminated
- 2016-01-15
- Reason
- Incorrect size printed on the Milex Pessary Kit packaging label
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 95 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot numbers: 144351, 142789
- 510(k) numbers
- ["K904026"]
- PMA numbers
- not on file
- Product code
- HHW
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28