Cincinnati, OH, United States
Devicor Medical Products Inc recalls
3 recalls recorded since 2018, most recently on 24 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 April 2026
- Reason
- Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2239-2026
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Terminated Class II Medical devices
- Recall started
- 30 March 2022
- Terminated
- 30 April 2024
- 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.
- Distribution
- US Nationwide distribution in the states of DE, KY, NY, OH, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1124-2022
- HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Terminated Class III Medical devices
- Recall started
- 7 September 2020
- Terminated
- 9 May 2023
- Reason
- It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
- Distribution
- The products were distributed only to China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0070-2021
- Neoprobe GDS Control Unit, Model Number NPCU3
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.