RecallRadar

FDA Device recall Z-0304-2026

Brand Name: Alcon Laboratories, Inc

On 2025-11-05 the FDA classified a Class II recall of Brand Name: Alcon Laboratories, Inc by Alcon Research, citing due to incomplete seals in the pouch which provide the sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0304-2026
ClassificationClass II
Statusongoing
Initiated2025-08-05
Published2025-11-05
Last updated2026-09-13 11:57 UTC
CompanyAlcon Research
DistributionUS

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' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

Reason

Due to incomplete seals in the pouch which provide the sterile barrier.

Identifiers

code_info
Catalog Number: 8065000250 UDI-DI code: 00380650002501 Lot/Batch Numbers: 17E6P1 17E77V Catalog Number: 8065753168 UDI…Catalog Number: 8065000250 UDI-DI code: 00380650002501 Lot/Batch Numbers: 17E6P1 17E77V Catalog Number: 8065753168 UDI-DI code: 00380657531684 Lot/Batch Number: 17EKTW Catalog Number: 8065753179 UDI-DI code: 00380657531790 Lot/Batch Number: 17E33N

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0304-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.