FDA Device recall Z-1959-2025
Extended Tip Applicator, 15 CM, Box of 5
- FDA Device
- Class I
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class I recall of Extended Tip Applicator, 15 CM, Box of 5 by Integra Lifesciences Neurosciences, citing devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1959-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-22 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
Extended Tip Applicator, 15 CM, Box of 5.
Reason
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Identifiers
| code_info | Model/Catalog Number: 205115; UDI: 10381780000150; All Lots. |
|---|
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-1959-2025%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.