CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report

Laparoscopic Prostatectomy recalled by AVID Medical

AVID Medical is recalling Laparoscopic Prostatectomy, distributed in 7 states. The recall was initiated on 11 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. NIHB0036-07; UDI: 10809160403099; Kit Lot No. 1589877, 1612565.
Quantity recalled30 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-2255-2025
FDA event ID
97149
Recalling firm
AVID Medical, Toano, VA
Classification
Class II
Status
Ongoing
Recall initiated
11 Jun 2025
FDA classified
4 Aug 2025
Reported
13 Aug 2025
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Sterility

Timeline

11 Jun 2025Recall initiated by company
4 Aug 2025Classified by FDA+54 days
13 Aug 2025Published in enforcement report+9 days

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

Reason for recall

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.

Where it was distributed

Domestic: CA, IL, MD, OH, PA, TX, WA.

CaliforniaIllinoisMarylandOhioPennsylvaniaTexasWashington

Questions about this recall

Is Laparoscopic Prostatectomy recalled?

Yes. AVID Medical recalled Laparoscopic Prostatectomy on 11 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2255-2025.

Why was it recalled?

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Which lots are affected?

Model No. NIHB0036-07; UDI: 10809160403099; Kit Lot No. 1589877, 1612565.

Where was it sold?

Domestic: CA, IL, MD, OH, PA, TX, WA.

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.

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