Non Siemens imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states over-reprocessing may compromise sterility or mechanical integrity, and no injuries are reported.
Plain-English summary
The ACUSON CATHETER ACUNAV Diagnostic Ultrasound 8FR, the variant not for use with Siemens systems, model ACU10135910, reprocessed by Sterilmed, is being recalled.
The affected catheters were reprocessed beyond validated cycles. Sterilmed states this may compromise device sterility or the mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
The recall covers 6 units carrying GTIN 10888551004725, across lots including 2196112 and 2200877. The product was distributed in Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas and Utah. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities holding affected units should quarantine them and follow Sterilmed's instructions.
The recalled product
- Product
- Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER…
- Manufacturer
- Sterilmed, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 6
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sterilmed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Sterilmed, Inc.
See all →- HighReprocessed imaging catheters recalled after exceeding validated reprocessing cycles
FDA (Devices) · 2025-11-26
- HighSterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns
FDA (Devices) · 2018-10-17
- SevereSterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
FDA (Devices) · 2018-01-03
- ModerateSterilmed Recalls Reprocessed EP Ablation Cables Due to Regulatory Status
FDA (Devices) · 2017-07-12
- HighSterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect
FDA (Devices) · 2016-06-08
Similar recalls
- CriticalReprocessed AcuNav catheters recalled over residual material particles inside
FDA (Devices) · 2026-02-18
- SevereSiemens ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Recalled for Perforation Risk
FDA (Devices) · 2020-10-14
- HighSterilmed Recalls Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters
FDA (Devices) · 2014-10-15
- CriticalReprocessed ultrasound catheters recalled over residual particulates on patient contacting surfaces
FDA (Devices) · 2025-10-08
- HighSiemens ACUSON Juniper ultrasound system recalled for intermittent power supply failure
FDA (Devices) · 2021-09-22
- HighAcuson 9vE4 Ultrasound Transducers Recalled for Potential Thermal Injury Risk
FDA (Devices) · 2022-05-04