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-2351-2026
- 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 20 Fr PULL Model/Catalog Number: 8180-20
Where it was distributed
US Nationwide distribution.
Questions about this recall
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?
Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
19 other products · FDA event 98907This product is part of a recall event; the main page for the event is Corflo* Safety PEG Kit with ENFit¿ Connector recalled by Avanos Medical.
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 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 |
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PUSH OTW recalled | Avanos Medical | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |