The device is a 25-gauge infusion line that is part of 25-gauge… — Class II medical device recall Z-2252-2021
Ongoing recall by Dutch Ophthalmic USA, Inc., reported 2021-08-18, distributed nationwide. Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
| Recall number | Z-2252-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dutch Ophthalmic USA, Inc., Exeter, NH, United States |
| Recall initiated | 2019-05-21 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 16 boxes |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08717872021294 |
| Lot numbers | 2000401997 |
| Model numbers | 25-GAUGE |
Product
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
Reason for recall
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
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-2252-2021. 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.