Recall archive / FDA device enforcement
Hemostasis Probe, Model: CD-B622LA — FDA record Z-1481-2024
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 Jan 5, 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
- Hemostasis Probe, Model: CD-B622LA
- Reason
- The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 36 units (all OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1481-2024
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 | Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution only.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 17, 2024
- Recall initiation date
- Jan 5, 2024
- Center classification date
- Apr 5, 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.