FDA Medical Device Recalls (openFDA)
Molnlycke Health Care, Inc: 9x15" Medium Utility Positioner with Cover
- Recall number
- Z-0417-2018
- Recalling firm
- Molnlycke Health Care, Inc
- Product
- 9x15" Medium Utility Positioner with Cover
- Status
- Terminated
- Initiated
- 2017-07-26
- Posted
- not on file
- Terminated
- 2021-04-06
- Reason
- Products may not meet specifications due to possible presence of metal shavings.
- Root cause
- Under Investigation by firm
- Action
- Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.
- Quantity
- 204 units total
- Distribution
- Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
- Lot, serial or model codes
- Recorder Code 1400239
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUW
- Firm FEI
- 1629080
- Firm city
- Norcross
- Firm state
- GA
- 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