FDA Device recall Z-1705-2025
Medline Sterile Water, USP, 100mL, REF RDI30295
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Medline Sterile Water, USP, 100mL, REF RDI30295 by Medline Industries Northfield, citing it was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1705-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-19 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Sterile Water, USP, 100mL, REF RDI30295
Reason
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Identifiers
| code_info | UDI/DI 10884389338230 (EA) 40884389338231 (CS), Lot Numbers: 23CJA159, 23GJA086, 23HJA080, 23JJA010, 23KJA047, 23LJA03…UDI/DI 10884389338230 (EA) 40884389338231 (CS), Lot Numbers: 23CJA159, 23GJA086, 23HJA080, 23JJA010, 23KJA047, 23LJA031, 23LJA089, 24AJA095, 24AJA157, 24CJA089, 24IJA004, 24IJA036, 24JJA164, 24KJA008, 24KJA051, 24KJA108. |
|---|
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-1705-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.