FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Milex Arcing Diaphragm Size 95; Model Number: MXWS95
- Recall number
- Z-1054-2016
- Recalling firm
- CooperSurgical, Inc.
- Product
- Milex Arcing Diaphragm Size 95; Model Number: MXWS95
- Status
- Terminated
- Initiated
- 2016-02-16
- Posted
- 2016-03-04
- Terminated
- 2016-03-29
- Reason
- The products have been identified to contain an incorrect size Diaphragm.
- Root cause
- Package design/selection
- Action
- Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement. For further questions, please call (203) 601-9818.
- Quantity
- 2 units
- Distribution
- US Distribution to the states of : OR and NY
- Lot, serial or model codes
- Lot# 130438
- 510(k) numbers
- ["K063223"]
- PMA numbers
- not on file
- Product code
- HDW
- 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