FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
- Recall number
- Z-2331-2024
- Recalling firm
- Integra LifeSciences Corp.
- Product
- AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
- Status
- Open, Classified
- Initiated
- 2024-06-07
- Posted
- 2024-07-11
- Terminated
- not on file
- Reason
- Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
- Root cause
- Process change control
- Action
- 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
- Quantity
- 14 units
- Distribution
- Domestic: NY, OH, & DC.
- Lot, serial or model codes
- Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
- 510(k) numbers
- K232618
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28