For intraventricular indications mainly used for operations within… — Class II medical device recall Z-2518-2023
Ongoing recall by Aesculap Implant Systems LLC, reported 2023-09-13, distributed nationwide. Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when
| Recall number | Z-2518-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2023-07-20 |
| Classified | 2023-09-06 |
| Reported by FDA | 2023-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| UPC / GTIN / UDI-DI | 04038653065547 |
| Lot numbers | 52750146, 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872 |
| Serial numbers | 4281, 4282, 4284, 4288, 4289, 4291, 4308, 4309, 4310, 4312, 4313, 4336, 4340, 4341, 4342, 4402, 4411, 4412, 4413, 4414, 4422, 4439, 4447, 4449, 4450 |
Product
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Reason for recall
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2518-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.