Z-2331-2024Class II

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager

Name: Z-2331-2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager
Creator: Integra LifeSciences Corp.
Published: 2024-06-07
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-06-07 / Open, Classified

FDA source

Integra LifeSciences Corp. began a recall of AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager on 2024-06-07. FDA classified it as Class II and gives the reason as "Potential sheath damage that could lead to tissue damage and/or track hemorrhage". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2331-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-07
Posted: 2024-07-11
Recalling firm: Integra LifeSciences Corporation
Product: AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Product code: GWG Endoscope, Neurological
Reason for recall: Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
FDA 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 [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]
Quantity in commerce: 14 units
Distribution: Domestic: NY, OH, & DC.
Product codes and lots: Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2331-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-10

Product code GWG

K232618Class IIAurora Surgiscope SystemRebound Therapeutics Corporation / cleared 2023-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)