a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV — Class III medical device recall Z-0490-2025
Ongoing recall by Alcon Research LLC, reported 2024-11-27, distributed in DE, IL, OK. Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling
| Recall number | Z-0490-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2024-10-15 |
| Classified | 2024-11-19 |
| Reported by FDA | 2024-11-27 |
| Distributed | DE, IL, OK |
| Quantity | 3,486 surgical |
| Reason classes | labeling, device malfunction |
Product
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.
Reason for recall
Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
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-0490-2025. 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.