Z-2331-2024 Class II Ongoing
FDA device recall Z-2331-2024 was initiated by Integra LifeSciences Corp. on Jun 7, 2024 and is designated Class II. Reason for recall: Potential sheath damage that could lead to tissue damage and/or track hemorrhage. The recall status is ongoing. Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 17, 2024
- Initiation Date
- Jun 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
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 Pattern
Domestic: NY, OH, & DC.
Code Information
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2331-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026