CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled
Avanos Medical is recalling MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors PULL, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2352-2026
- FDA event ID
- 98907
- Recalling firm
- Avanos Medical, Alpharetta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 30 Apr 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +36 days |
| 17 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors PULL recalled?
Yes. Avanos Medical recalled MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors PULL on 30 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2352-2026.
Why was it recalled?
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Which lots are affected?
UDI-DI 10350770007868, Lot Numbers 30371319, 30374055, 30383058, 30386936
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avanos Medical
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PUSH OTW recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PULL recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled | Avanos Medical | Sterility | Nationwide |
| Device | CLASS II | Corflo Safety PEG Kit with ENFit Connector recalled by Avanos Medical | Avanos Medical | Sterility | Nationwide |
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