MIC* Percutaneous Endoscopic Gastrostomy PEG Kit — Class II medical device recall Z-0565-2022
Terminated recall by Avanos Medical, Inc., reported 2022-02-16, distributed nationwide. The External Retention Bolster contained in the kit may be a larger diameter than the tube.
| Recall number | Z-0565-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2021-12-22 |
| Classified | 2022-02-07 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2023-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL |
| Quantity | 2,652 units |
| Lot numbers | 30116959, 30129345, 30132543, 30132545, 30132546 |
Product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Reason for recall
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0565-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.