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OWL

Diros Technology Inc · Model DHC-018/150/10-SC · UDI-DI 00825114002425

GXI Prescription

510(k) clearances

897

Adverse events (6 deaths)

Recalls

Facilities

Description

OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (18 Ga.) 150mm LONG, 10mm BARE TIP

Recalls

Date	Firm	Reason
2026-04-29	Boston Scientific Neuromodulation Corporation	Reusable electrodes may not meet expected performance levels.
2026-04-29	Boston Scientific Neuromodulation Corporation	Reusable electrodes may not meet expected performance levels.
2026-04-22	Boston Scientific Neuromodulation Corporation	Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to
2024-06-03	Stryker Corporation	Expired Products distributed to customers
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-02-21	Epimed International	Incorrect expiration date on introduction cannula packaging.

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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.