Vygon Dressing Change w/ Maxiswab — Class II medical device recall Z-1689-2021
Ongoing recall by Vygon U.S.A., reported 2021-06-09, distributed nationwide. Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential
| Recall number | Z-1689-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon U.S.A., Lansdale, PA, United States |
| Recall initiated | 2021-04-15 |
| Classified | 2021-05-28 |
| Reported by FDA | 2021-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 8,320 units |
| Reason classes | sterility |
| Lot numbers | 203373129 |
| Expiration dates | 2022-06-30 |
Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Reason for recall
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
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-1689-2021. 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.