Medline Contro-Bulb Syringe — Class II medical device recall Z-1157-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-25, distributed nationwide. Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Med
| Recall number | Z-1157-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-01-04 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,831 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196031764, 40080196031765 |
| Lot numbers | 96922110001, 96923100001 |
| Model numbers | DYND20125 |
Product
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Reason for recall
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
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-1157-2024. 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.