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MiniONE Balloon Button

APPLIED MEDICAL TECHNOLOGY, INC. · Model SM1-5-1420 · UDI-DI 00842071142575

KNT Prescription
2
510(k) clearances
25,839
Adverse events (628 deaths)
268
Recalls
228
Facilities

Description

14FR x 2.0 cm MiniONE Balloon Button Single Pack - Low Profile Feeding Device, MDR

Recalls

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