PlainRecordsBrand Name: Alcon Laboratories…
- Reason
- Ophthalmic procedure packs may have incomplete seals affecting sterility.
- Status
- Ongoing
- Distribution
- US Nationwide distribution in the states of CA, ND, UT.
- Enforcement report date
- Dec. 31, 2025
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Alcon Research LLC
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
- Reason
- Ophthalmic procedure packs may have incomplete seals affecting sterility.
- Distribution pattern
- US Nationwide distribution in the states of CA, ND, UT.
- Quantity
- 151 units
- Codes and lots
- UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
- Recall started
- Nov. 24, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- General Surgery Tray
- Root cause (FDA)
- Packaging
- What the company told customers
- On November 24, 2025, Alcon issued a Urgent Medical Device Notification to affected consignees. Alcon ask affected consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. 2. Segregate and dispose of any unused affected product from your inventory. 3. Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak. 4. Respond to Alcon indicating your understanding of these instructions. 5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.
- Recall number
- Z-0939-2026
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Ophthalmic procedure packs may have incomplete seals affecting sterility.”Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A, FDA enforcement report, 2025-12-31. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: General Surgery Tray
Distributed in (FDA's record): California North Dakota Utah and nationwide
This recall among the others
- FDA's enforcement report came 37 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Alcon Research: 18 other recalls or notices on this site in the three years before this one (from Jan. 1, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0939-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0939-2026, Dec. 31, 2025. "Brand Name: Alcon Laboratories." PlainRecords, https://plainrecords.com/recall/device/z-0939-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections