FDA Medical devices recall ·

LAPAROSCOPIC PROSTATECTOMY recall

Recall number
Z-0099-2027
Date
(initiated August 10, 2026)
Company / brand
AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
15
Hazard tags
Microbial contamination
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;

Why was it recalled?

Product may be potentially contaminated with a lubricant used during the manufacturing process.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model/Item Number (Kit): NIHB0036-07; UDI-DI: 10809160403099; Kit Lot Numbers: 1657751; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKT3375;

Distribution

US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

States: Arizona California Florida Maryland Nebraska Texas

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0099-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.