WhichRecall
Class I — UrgentReported 2026-02-18

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

Recalled by Medline Industries, LP

Reason for Recall

These lots of reprocessed catheters may contain small particles of residual material

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If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

Recall Number
Z-1325-2026
Classification
Class I
Status
Ongoing
Category
device
Initiated
2025-12-22
Reported
2026-02-18
Distribution
Distribution US nationwide.
Code Info
10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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