Recall Z-1324-2026
Medline Industries, LP · initiated December 22, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
Codes / lots: 10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
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-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1324-2026
- Initiated
- December 22, 2025
- Posted by FDA
- February 6, 2026
- Product code
- OWQ – Reprocessed Intravascular Ultrasound Catheter
- Quantity
- 94
- Distribution
- Distribution US nationwide.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1319-2026 Class I | Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | 12/22/2025Open, Classified |
| Z-1320-2026 Class I | Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | 12/22/2025Open, Classified |
| Z-1321-2026 Class I | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | 12/22/2025Open, Classified |
| Z-1322-2026 Class I | Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St.…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | 12/22/2025Open, Classified |
| Z-1323-2026 Class I | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | 12/22/2025Open, Classified |
| Z-1325-2026 Class I | Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | 12/22/2025Open, Classified |