XEN Gel Stent — Class II medical device recall Z-0598-2020
Ongoing recall by Allergan PLC, reported 2019-12-11, distributed nationwide. Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the
| Recall number | Z-0598-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergan PLC, Irvine, CA, United States |
| Recall initiated | 2019-10-30 |
| Classified | 2019-12-04 |
| Reported by FDA | 2019-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 145,711 glaucoma |
| Reason classes | foreign material, sterility |
| UPC / GTIN / UDI-DI | 10888628032439 |
| Lot numbers | 61566, 61580, 61626, 61642, 61650, 61657, 61685, 61779, 61780, 61825, 61846, 61847, 61883, 61884, 61906, 61911, 61955, 61966, 62008, 62053, 62066, 62108, 62130, 62263, 62297, 62301, 62318, 62380, 62538, 62578, 62608, 62636, 62678, 62683, 62703, 62719, 62745, 62749, 62769, 62812 and 3 more |
| Model numbers | 5507-001, 5513-001 |
Product
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
Reason for recall
Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.
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-0598-2020. 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.