Integra LifeSciences Corp. 2025-03-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1295-2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator,… Recall
Issued March 12, 2025 · Integra LifeSciences Corp.
In March 2025, Integra LifeSciences Corp. recalled the AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Possibility for the obturator to break (separate).
What you should do
- 1 Stop using AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Integra LifeSciences Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Integra LifeSciences Corp.
- Category
- Health
- Recall date
- March 12, 2025
- Units affected
- Not reported
- Sold at
- 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.
- Recall number
- FDA-Z-1295-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Integra LifeSciences Corp. has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.