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Navina™ Smart System

Wellspect AB · Model 69109 · UDI-DI 07333387052625

KNT FCE Prescription

510(k) clearances

25,972

Adverse events (630 deaths)

268

Recalls

228

Facilities

Description

Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.

Recalls

Date	Firm	Reason
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30	Avanos Medical, Inc.	Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

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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.