FDA Device recall Z-0312-2026
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description… by Aesculap, citing it was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0312-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-24 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Aesculap |
| Distribution | US |
Product
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Reason
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Identifiers
| code_info | Model No EK087P; UDI-DI: 04046963620059; Lots 52974276, 52952133, 52954633, 52959357, 52964442, 52968887, 52972214, 52…Model No EK087P; UDI-DI: 04046963620059; Lots 52974276, 52952133, 52954633, 52959357, 52964442, 52968887, 52972214, 52977427, 52981208, 52985519, 52988828, 52992514, 52993617, 52997919, 53002094, 53004347, 53006380, 53007625, 53010869, 53013557 |
|---|
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-0312-2026%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.