CLASS II ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report

Aurora Surgiscope System recalled by Integra LifeSciences

Integra LifeSciences is recalling Aurora Surgiscope System, distributed in District of Columbia, New York, Ohio. The recall was initiated on 7 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.

Quantity recalled14 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2331-2024
FDA event ID: 94804
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jun 2024
FDA classified: 10 Jul 2024
Reported: 17 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

7 Jun 2024	Recall initiated by company
10 Jul 2024	Classified by FDA	+33 days
17 Jul 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

Domestic: NY, OH, & DC.

District of Columbia New York Ohio

Questions about this recall

Is Aurora Surgiscope System recalled?

Yes. Integra LifeSciences recalled Aurora Surgiscope System on 7 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2331-2024.

Why was it recalled?

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Which lots are affected?

Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.

Where was it sold?

Domestic: NY, OH, & DC.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Integra LifeSciences

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