FDANovember 14, 2023device
BD Recanalization System, REF: BDRECANSYSTEM
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
What to do
FDA enforcement status: Ongoing
Brands named
bard peripheral vascularbardbard peripheral
UPCs
00801741202421
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASilastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 336242026-04-23
- FDAArtegraft Vascular Graft; REF#: AG740;2026-02-10
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDABD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 7884262025-11-06
- FDABD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 7886302025-11-06
- FDABD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 788262025-11-06
- FDASafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,2025-11-06
- FDABard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 7876142025-11-06
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