Z-1325-2026Class I

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on...

Name: Z-1325-2026 Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on...
Creator: Medline Industries, LP
Published: 2025-12-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-22 / Open, Classified

FDA source

Medline Industries, LP began a recall of Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav... on 2025-12-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1325-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-12-22
Posted: 2026-02-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: OWQ Reprocessed Intravascular Ultrasound Catheter
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.
Quantity in commerce: 511
Distribution: Distribution US nationwide.
Product codes and lots: 10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1325-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1320-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1321-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1322-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1323-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1324-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1325-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

Product code OWQ

K234064Class IIMedline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service and Savings, Inc. / cleared 2024-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)