AURORA Surgiscope recallZ-2331-2024 · Integra LifeSciences Corp. · initiated Jun 7, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
FDA root cause category: Process change control
What the company is doing
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 [email protected] 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 [email protected]
Recall details
- Recall number
- Z-2331-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 7, 2024
- Posted by the FDA
- Jul 11, 2024
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 14 units
- Product code
- GWG
- FDA submissions
- K232618
- Distribution
- Domestic: NY, OH, & DC.
Product description
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Code information (models, lots, serial numbers)
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K232618 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Aurora® Surgiscope® ASX9/100Integra Lifesciences Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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