CXR Preconnect with TENACIO Pump with InhibiZone — Class II medical device recall Z-0143-2026
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-0143-2026 |
|---|---|
| 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 | 172 units |
| UPC / GTIN / UDI-DI | 00191506021504, 00191506021511, 00191506021528, 00191506021535, 00191506021542, 00191506021559, 00191506021566, 00191506021573, 00191506021580 |
| Lot numbers | 1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540, 1100398541, 1100398542, 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100480549, 1100480550, 1100480551, 1100480552, 1100480553, 1100480555, 1100480556, 1100480557, 1100480558, 1100480559, 1100480561, 1100480562, 1100480567, 1100480568, 1100489492, 1100489493, 1100489494, 1100489495, 1100489496, 1100489497, 1100489498, 1100489542 and 321 more |
Product
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);
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-0143-2026. 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.