FDA recall Z-2331-2024

Product

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

Reason for recall

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Distribution

Domestic: NY, OH, & DC.

Key facts

Status

Ongoing

Initiation date

2024-06-07

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2024