FDA Device recall Z-0807-2025
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUN…
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUN… by Stryker, citing bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provid….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0807-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-03 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | GA, IL, WA |
Product
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
Reason
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
Identifiers
| code_info | 0703 002 000ENG GTIN 07613327382082, Lot Numbers; 2427418723 2427423863 2427418453 2427423873…0703 002 000ENG GTIN 07613327382082, Lot Numbers; 2427418723 2427423863 2427418453 2427423873 2427418743 2427419773; 0703 002 000ES GTIN 07613327382068, Lot Numbers: 2427418453; 0703 003 000 GTIN 07613327381948, Lot Numbers: 2427418093 2427418053 2427418073 2427418233 2427418013 2427418723; 0711 001 000 GTIN 07613327576887, Lot Numbers: 2429720623 2429721033 2429720903 2429721203 2429720973 2429721223 2429721023 2303501403 2323610223 2403600253; |
|---|
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-0807-2025%22
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