Integra LifeSciences Corp. AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
Model No. ASX9/130, UDI# 00850002332278, Lot No. 7336314.
Products Sold
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Integra LifeSciences Corp. is recalling AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. due to Potential sheath damage that could lead to tissue damage and/or track hemorrhage.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Recommended Action
Per FDA guidance
A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter, dated 6/7/24, was mailed to consignees. The notification instructs consignees to immediately remove any affected devices from service and place them in quarantine. The recall notification is to be forwarded to users of the product within your facility for their awareness. Consignees are to complete the provided response form and return it via email to FCA3@integralife.com or by fax to 1-609-750-4220. Integra Customer Service will reach out to consignees regarding a Return Materials Authorization and return directions upon receipt of the response form. Consignees with any questions are to contact Customer Service from 8:00 AM to 8:00 PM from Monday to Friday by phone at 1-800-654-2873 or by email at custsvcnj@integralife.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY, OH, DC
Page updated: Jan 10, 2026