CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
Vista Brite Tip, Judkins Right recalled by Cordis US
Cordis US is recalling Vista Brite Tip, Judkins Right 4, distributed in Washington. The recall was initiated on 7 Feb 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-1330-2025
- FDA event ID
- 96272
- Recalling firm
- Cordis US, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Feb 2025
- FDA classified
- 13 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 7 Feb 2025 | Recall initiated by company | |
| 13 Mar 2025 | Classified by FDA | +34 days |
| 19 Mar 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
Catheter manufactured at the incorrect length.
Product as listed by the FDA
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Where it was distributed
US: WA OUS: Japan
Questions about this recall
Why was it recalled?
Catheter manufactured at the incorrect length.
Which lots are affected?
UDI: 20705032042991/ Lot Number: 18368326
Where was it sold?
US: WA OUS: Japan
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.
More recalls from Cordis US
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cordis, REF: C09060ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Cordis, REF C10040ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Mynxgrip 6f/7f recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
| Device | CLASS II | Mynxgrip 5F recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
| Device | CLASS I | Cordis Angiographic Catheterization Sets, Infiniti Thrulemen, 5F recalled | Cordis US | Sterility | OK |
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 |