Home › SCION MEDICAL TECHOLOGIES, LLC › BEACON

BEACON

SCION MEDICAL TECHOLOGIES, LLC · Model BM1412-50-1 · UDI-DI 00866479000107

NEU

510(k) clearances

1,870

Adverse events (1 deaths)

Recalls

102

Facilities

Description

Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) aswell as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. Beacon Tissue Marker/Beacon Tissue Marker (SE) is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. Beacon Tissue Marker/Beacon Tissue Marker (SE) is supplied pre-loaded in the delivery device. The Beacon Tissue Marker delivery device has a beveled 12cm/14G needle with 1cm depth marks and a plunger. The Beacon Tissue Marker (SE) delivery device has a radiused tip 12cm/14G cannula with 1cm depth marks anda plunger.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.