Z-1295-2025Class II

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

Name: Z-1295-2025 AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager...
Creator: Integra LifeSciences Corp.
Published: 2025-02-06
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-02-06 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1)... on 2025-02-06. FDA classified it as Class II and gives the reason as "Possibility for the obturator to break (separate)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1295-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-06
Posted: 2025-03-06
Recalling firm: Integra LifeSciences Corporation
Product: AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Product code: GWG Endoscope, Neurological
Reason for recall: Possibility for the obturator to break (separate).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 6, 2025, URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the lot number(s) and total quantity of the affected product that you have. 3. Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas. 4. If you do not have affected product, check the box, I do not have affected product. 5. Complete the rest of the Acknowledgement Form and return to [email protected] or FAX to 1-609-750- 4220. 6. Keep a copy of the form for your records. 7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit for the quantities returned. Please note credit is applicable only for unexpired product. Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and the signed copy of the acknowledgement form for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] In addition, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mai
Quantity in commerce: 623 units
Distribution: 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.
Product codes and lots: Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1295-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-06

Product code GWG

K201840Class IIAurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics / cleared 2020-11-04

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)