The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0306-2026·Announced 2025-11-05

Surgical console accessories recalled over incomplete seals in sterile pouches

Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

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: Scored 3 under the risk-of-harm criterion: a failed sterile barrier on a surgical accessory creates an infection risk, and no injuries are reported.

Plain-English summary

Accessory devices for Alcon Unity and Constellation surgical consoles are being recalled. The affected item identified in the record is catalog number 8065000393, the UNITY HP Viscous Fluid Control VFC Pack, with the firm referring to a fuller affected product list.

The recall follows incomplete seals in the pouch which provides the sterile barrier.

The recall covers 6 units carrying UDI-DI 00380650003935, from lot 17CDKX. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

An incomplete seal means the sterile barrier may not have held. Facilities holding the affected lot should quarantine it and follow Alcon's instructions.

The recalled product

Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product…
Manufacturer
Alcon Research LLC
Category
Medical Device — Surgical accessory
Hazard
Affected units
6

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 (1)

  • Catalog Number: 8065000393 UDI-DI code: 00380650003935 Lot/Batch Number: 17CDKX

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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