FDA Device recall Z-0143-2026

CXR Preconnect with TENACIO Pump with InhibiZone

FDA Device
Class II
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class II recall of CXR Preconnect with TENACIO Pump with InhibiZone by Boston Scientific, citing the potential for devices to experience inflation and/or deflation performance issues or difficulties.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0143-2026
Classification	Class II
Status	ongoing
Initiated	2025-09-11
Published	2025-10-22
Last updated	2026-09-13 11:57 UTC
Company	Boston Scientific
Distribution	US

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

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Identifiers

code_info	1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 110… 1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ); UDI-DI: 00191506021511; Lot numbers: 1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714,

code_info

1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 110…

1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ); UDI-DI: 00191506021511; Lot numbers: 1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714,

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-0143-2026%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.