Recall archive / FDA device enforcement
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22... — FDA record Z-2268-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
- Reason
- Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
- Classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2268-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Japan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 10, 2024
- Recall initiation date
- May 10, 2024
- Center classification date
- Jul 3, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.