AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Reported: March 12, 2025 Initiated: February 6, 2025 #Z-1295-2025
Product Description
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Reason for Recall
Possibility for the obturator to break (separate).
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 623 units
- Distribution
- US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80. Recalled by Integra LifeSciences Corp.. Units affected: 623 units.
Why was this product recalled? ▼
Possibility for the obturator to break (separate).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2025. Severity: Moderate. Recall number: Z-1295-2025.
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