CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Catheter Acunav Diagnostic Ultrasound Not For Use recalled by Sterilmed
Sterilmed is recalling Catheter Acunav Diagnostic Ultrasound Not For Use With Siemens System, distributed in 8 states. The recall was initiated on 8 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0573-2026
- FDA event ID
- 97803
- Recalling firm
- Sterilmed, Plymouth, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Oct 2025
- FDA classified
- 20 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 8 Oct 2025 | Recall initiated by company | |
| 20 Nov 2025 | Classified by FDA | +43 days |
| 26 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
Where it was distributed
United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
KentuckyMassachusettsMarylandMississippiNew JerseyPennsylvaniaTexasUtah
Questions about this recall
Why was it recalled?
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Which lots are affected?
Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759
Where was it sold?
United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97803| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Reprocessed Imaging Catheter Acuson recalled by Sterilmed | Sterilmed | Sterility | 8 states |
More recalls from Sterilmed
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Reprocessed Imaging Catheter Acuson recalled by Sterilmed | Sterilmed | Sterility | 8 states |
| Device | CLASS II | Reprocessed Agilis Steerable Introducer: indicated recalled by Sterilmed | Sterilmed | Device Malfunction | Nationwide |
| Device | CLASS I | St. Jude Medical recalled by Sterilmed | Sterilmed | Packaging Defects | Nationwide |
| Device | CLASS II | Electrophysiology catheter cables are designed as electrode recalled | Sterilmed | Other | 17 states |
| Device | CLASS II | Reprocessed Microline Scissor Tips intended to be used recalled | Sterilmed | Device Malfunction | 28 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |