FDA Device recall Z-1157-2024
Medline Contro-Bulb Syringe, REF DYND20125
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of Medline Contro-Bulb Syringe, REF DYND20125 by Medline Industries Northfield, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1157-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-04 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Reason
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).
Identifiers
| code_info | UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2024%22
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