LGX Preconnect with TENACIO Pump without InhibiZone — Class II medical device recall Z-0141-2026
Ongoing recall by Boston Scientific Corporation, reported 2025-10-22, distributed nationwide. The potential for devices to experience inflation and/or deflation performance issues or difficulties.
| Recall number | Z-0141-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 0 units |
| UPC / GTIN / UDI-DI | 00191506021252, 00191506021276 |
| Lot numbers | 1100676894, 1100676895, 1100687060, 1100687061, 72404407 |
Product
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Reason for recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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-0141-2026. 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.