RecallRadar

FDA Device recall Z-0620-2024

regard Operative LAP, Item Number 800943001

On 2024-01-24 the FDA classified a Class I recall of regard Operative LAP, Item Number 800943001 by Roi Cps, citing surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0620-2024
ClassificationClass I
Statusterminated
Initiated2023-12-18
Published2024-01-24
Last updated2026-09-13 11:57 UTC
CompanyRoi Cps
DistributionLA

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.

Identifiers

code_infoUDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0620-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.