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Gel Mark UltraCor® Breast Tissue Marker
SENORX, INC. · Model GMUTC005T · UDI-DI 00801741031908
NEU
Prescription
1
510(k) clearances
1,851
Adverse events (1 deaths)
14
Recalls
101
Facilities
Description
GEL MARK ULTRACOR Marker, 14 Gauge, Titanium "S"Breast Tissue
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Devicor Medical Products Inc | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| 2026-01-21 | Stryker Corporation | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedure |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2024-11-18 | Elucent Medical Inc | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when |
| 2024-10-10 | Hologic, Inc | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
| 2024-03-13 | Hologic, Inc | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complication |
| 2022-12-16 | Carbon Medical Technologies, Inc. | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shap |
| 2022-08-09 | Hologic, Inc | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expirat |
| 2022-03-30 | Devicor Medical Products Inc | 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 incorrectl |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.