AURORA Surgiscope System. Sterile recall
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Why was AURORA Surgiscope System. Sterile recalled?
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
- Product
- AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 14 units
- Distribution
- Domestic: NY, OH, & DC.
- Recall date
- July 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)