FDA Device recall Z-1433-2024
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505 by Medline Industries Northfield, citing product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1433-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-23 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
Reason
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Identifiers
| code_info | UDI/DI 00653160294453 (case), 10653160294450 (unit), Lot Numbers: 2023090190, 2023101190 |
|---|
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-1433-2024%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.