FDA Medical Device Recalls (openFDA)
Devicor Medical Products Inc: HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- Recall number
- Z-1124-2022
- Recalling firm
- Devicor Medical Products Inc
- Product
- HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- Status
- Terminated
- Initiated
- 2022-03-30
- Posted
- not on file
- Terminated
- 2024-04-30
- Reason
- Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
- Root cause
- Labeling Change Control
- Action
- On March 30, 2022, the firm distributed Urgent Medical Device Recall letters to their customers via email. Customers were informed of the labeling issue. Users were instructed to examine their inventory and identify any affected product. Users should contact their local sales representative for correction of any affected devices. The sales representative will be on site to remove the affected patient labels. Please do not use affected patient labels from this lot. If you have any additional questions, comments or concerns please contact the firm's Customer Support at +1 877-926-2666. You may also email mmtchnrecall@mammotome.com.
- Quantity
- 90 devices
- Distribution
- US Nationwide distribution in the states of DE, KY, NY, OH, WV.
- Lot, serial or model codes
- UDI-DI: 00841911102472 Lot F12201281D
- 510(k) numbers
- ["K210752"]
- 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