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Recall Observatory FDA recall evidence

Device product

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20

Z-2348-2026

April 30, 2026

Class II

Product summary

Firm
Avanos Medical, Inc.
Event
Event 98907
Status
Ongoing
Classification
Class II
Quantity
1,615 kits
Official record key
device-enforcement:Z-2348-2026

Official wording

Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Code information: UDI-DI 10350770007820, Lot Numbers 30371324, 30374833, 30384889, 80403350

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.