FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
- Recall number
- Z-1814-2015
- Recalling firm
- CooperSurgical, Inc.
- Product
- MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
- Status
- Terminated
- Initiated
- 2015-05-20
- Posted
- 2015-06-18
- Terminated
- 2016-01-20
- Reason
- A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
- Root cause
- Labeling mix-ups
- Action
- CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. .
- Quantity
- 200 units
- Distribution
- AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
- Lot, serial or model codes
- Lot 153309
- 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