AURORA Surgiscope System Obturator May Break or Separate
Integra LifeSciences Corp. is recalling AURORA Surgiscope Systems (models ASX15/60 and ASX15/80) because the obturator component may break or separate during surgical use. Healthcare facilities should discontinue use and contact the manufacturer for instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a critical surgical component that may break or separate during use. The potential mechanical failure presents a risk of harm during surgical procedures, meeting the criteria for High severity under the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Integra LifeSciences Corp. is recalling the AURORA Surgiscope System, a sterile, single-use surgical device. The recall affects 623 units with catalog numbers ASX15/60 and ASX15/80.
The obturator component of the device may break or separate during use. This mechanical failure could compromise the device's functionality during surgical procedures.
The affected devices were distributed nationwide to healthcare facilities across 19 states and the District of Columbia, including Missouri, Florida, Texas, New York, Illinois, Ohio, New Jersey, California, Minnesota, Washington, Tennessee, Maryland, Louisiana, Oklahoma, South Carolina, Pennsylvania, Michigan, Kentucky, and North Carolina.
Healthcare facilities should immediately stop using the recalled devices and contact Integra LifeSciences Corp. for instructions on return or replacement. Facilities should check their inventory for catalog numbers ASX15/60 and ASX15/80, specifically all unexpired lots.
The recalled product
- 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
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 623
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog Number: (1) ASX15/60 (2) ASX15/80
- UDI-DI: (1) 00850002332254
- (2) 008500023332247
- Lot No. (1) All unexpired lots
- (2) All unexpired lots.
Distribution
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