VYGON DRESSING CHANGE W/MAXISWAB kit — Class II medical device recall Z-1688-2022
Ongoing recall by Stradis Healthcare, reported 2022-09-14, distributed in PA. Potential for incomplete seals.
| Recall number | Z-1688-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Healthcare, Waukegan, IL, United States |
| Recall initiated | 2022-05-10 |
| Classified | 2022-09-08 |
| Reported by FDA | 2022-09-14 |
| Distributed | PA |
| Quantity | 520 units |
| UPC / GTIN / UDI-DI | 00849884005622 |
| Lot numbers | 220614962 |
| Model numbers | AMS-8465CS |
| Expiration dates | 2023-04-30 |
Product
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Reason for recall
Potential for incomplete seals.
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-1688-2022. 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.