SYRINGE — Class II medical device recall Z-1370-2024
Ongoing recall by Alcon Research, LLC, reported 2024-04-03, distributed nationwide. Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and t
| Recall number | Z-1370-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2024-02-21 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 886 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00380651682849, 00380651693326, 00380655143711, 00380655148150, 00380655148174, 00380655148303, 00380655148440, 00380655149140, 00380655149683 |
| Lot numbers | 96922110001, 96923100001 |
| Model numbers | 300055070 |
Product
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15
Reason for recall
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
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-1370-2024. 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.