Reported Mar 12, 2025 · Ongoing
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- 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
- Lot codes and dates
- Catalog Number(1) ASX15/60 (2) ASX15/80
- UDI-DI
(1) 00850002332254(2) 008500023332247Lot No. (1) All unexpired lots(2) All unexpired lots
- Amount recalled
- 623 units
Where it was sold
Why it was recalled
Possibility for the obturator to break (separate).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Integra LifeSciences Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.