Recall archive / FDA device enforcement
regard Operative LAP, Item Number 800943001; surgical convenience kit — FDA record Z-0620-2024
Reported terminated
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 Dec 18, 2023. 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
- regard Operative LAP, Item Number 800943001; surgical convenience kit
- Reason
- Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- Classification
- Class I
- Recalling firm
- ROi CPS LLC
- Quantity
- 345 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0620-2024
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/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Louisiana
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Dec 18, 2023
- Center classification date
- Jan 12, 2024
- Termination date
- Oct 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.