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Medline Industries, LP: Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 1004

Medical DevicesSource: FDA (device) · Date: 2026-02-18

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
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
Reason / hazard
These lots of reprocessed catheters may contain small particles of residual material. 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
Classification
Class I
Status
Ongoing
Distribution / sold at
Distribution US nationwide.
Recall initiated
2025-12-22
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
Product quantity
511
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98277
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