CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Reprocessed Imaging Catheter Acuson recalled by Sterilmed
Sterilmed is recalling Reprocessed Imaging Catheter Acuson, Catheter Acunav Diagnostic Ultrasound For Use With, 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-0574-2026
- 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: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR 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: 10888551004732 LOT# SERIAL#: 2188147 131065 2207154 916179 2220232 1050886 2234795 1170283
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 97803This product is part of a recall event; the main page for the event is Catheter Acunav Diagnostic Ultrasound Not For Use recalled by Sterilmed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Catheter Acunav Diagnostic Ultrasound Not For Use recalled by Sterilmed | Sterilmed | Sterility | 8 states |
More recalls from Sterilmed
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Catheter Acunav Diagnostic Ultrasound Not For Use 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 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |