Avanos PEG Kit with ENFit Connectors: Risk of Incorrect Tube Fit
Avanos Medical recalls PEG kits with ENFit connectors due to potential mismatch between retention bolster and tube diameter. Affected kits include specific lot numbers from 2023.
Lower-risk recall
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Contact the company
What happened, in plain English
Avanos Medical is recalling PEG kits with ENFit connectors because the retention bolster might be too large for the tube, which could cause improper fitting. This could lead to complications if the tube isn't secured correctly. Read more at govinfonow.com/recall/61372-avanos-peg-kit-with-enfit-connectors-risk-of-incorrect-tube.
Source Summary by GovInfoNow · govinfonow.com/recall/61372-avanos-peg-kit-with-enfit-connectors-risk-of-incorrect-tube · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0566-2022
Cite this page
“Avanos PEG Kit with ENFit Connectors: Risk of Incorrect Tube Fit.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61372-avanos-peg-kit-with-enfit-connectors-risk-of-incorrect-tube. Based on FDA recall #Z-0566-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0566-2022%22&limit=1).
Why it’s dangerous
The retention bolster in the kit might be a larger diameter than the tube it's designed to hold. This mismatch could cause the tube to become loose or dislodged during use, potentially leading to complications like leaks or infections.
Who’s affected
Patients who have received the specific lot numbers of the PEG kits (8160-20 Lot 30135103 or 8640-20 Lot 30132544) are most at risk. Healthcare providers using these kits for medical procedures may also be affected.
How to tell if you have this one
Check the product label for the model code and lot number. Affected kits include Code 8160-20 Lot 30135103 or Code 8640-20 Lot 30132544.
- Brand
Avanos- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0565-2022 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL; 1) Code 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345 | 2652 units |
| Z-0566-2022 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL; 1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544 | 692 units |
What to do — step by step
Check Product Label
Look for the model code and lot number on the kit packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada and Chile.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0566-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0566-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.