Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
FDA Recall Z-2352-2026 · Posted 2026-06-05
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Recalling FirmAvanos Medical, Inc.
Recall StatusOpen, Classified
Product CodeKNT
Date Initiated2026-04-30
Product Quantity1,205 kits
Reason for Recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Firm Action
On May 1, 2026, Avanaos Medical, Inc. issued a "Urgent: Medical Device Recall" Notification to affected consignees via Email. Avanos asked consignees to take the following actions:
1. Immediately review your inventory and identify any affected product.
1a. Quarantine all affected lots to prevent further use or distribution.
1b. Discontinue use of the affected lidocaine hydrochloride injection 1%, 5 mL and return the entire unused kit to Avanos Medical, Inc. for destruction.
2. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred.
3. Complete and return the Customer Response Form as instructed, including identifying whether you have inventory of the affected product available for return.
Distributors:
1. Provide customers a copy of this notification. Instruct customers to follow the actions outlined in this letter.
2. Provide refunds or credits to your customers in accordance with your internal processes.
3. Submit an updated Customer Response Form to Avanos to account for product distributed to your customers and to receive applicable replacement product.
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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