FDA Medical Device Recalls (openFDA)
Devicor Medical Products Inc: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Recall number
- Z-2239-2026
- Recalling firm
- Devicor Medical Products Inc
- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Status
- Open, Classified
- Initiated
- 2026-04-24
- Posted
- 2026-05-27
- Terminated
- not on file
- Reason
- Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
- Root cause
- Labeling mix-ups
- Action
- An URGENT FIELD SAFETY RECALL was sent to customers beginning 4/24/26. Action to be taken by the user: As a result of this notification, please conduct the following: "Examine your inventory and identify any devices from Lot F12607207D. "Immediately remove from use any devices labeled as 4010 02 15 T4 from this lot. "Contact your local sales representative to coordinate next steps. The affected product (devices labeled as4010 02 15 T4 from lot F12607207D) may either: -Be handed to a sales representative for removal, or -Be disposed of at your facility in accordance with local and institutional disposal requirements. "If a marker from this lot has already been implanted, review and update patient records as appropriate. "Complete and return the Recall Response Form (included with this notification), even if you no longer have affected product, to confirm the receipt of this notice and completion of required actions. If you have any additional questions, comments or concerns please contact our Customer Support at +1 877-926-2666. You may also email Vivian.boyd@mammotome.com.
- Quantity
- 1910 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
- Lot, serial or model codes
- Lot Number: F12607207D
- 510(k) numbers
- ["K212158"]
- PMA numbers
- not on file
- Product code
- NEU
- Firm FEI
- 3008492462
- Firm city
- Cincinnati
- Firm state
- OH
- 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