Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 5, 2025
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' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products
Due to incomplete seals in the pouch which provide the sterile barrier.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alcon Research LLC recalled Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Const… - a moderate-severity action.
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Const… was recalled by Alcon Research LLC in November 5, 2025. Reason: Due to incomplete seals in the pouch which provide the sterile barrier.. Check the official notice for the remedy. Verify recall #Z-0305-2026 with the FDA Devices before acting.
The recall
Alcon Research LLC issued this moderate-severity FDA Devices recall-Due to incomplete seals in the pouch which provide the sterile barrier..
- Moderate
- severity level
- 26K units
- affected scope
- Class II
- classification
- November 5, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0305-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0305-2026) was formally reported on November 5, 2025, with the manufacturer initiating the action on August 5, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Alcon Research LLC is listed as the recalling firm, operating out of Fort Worth, TX. Federal records list the affected scope as 25,778.
The documented reason for this recall is: Due to incomplete seals in the pouch which provide the sterile barrier. Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25,778
Related Recalls
6
3 from same agency
Product description
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' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID 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 for recall
Due to incomplete seals in the pouch which provide the sterile barrier.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0305-2026 |
| Date reported | November 5, 2025 |
| Date initiated | August 5, 2025 |
| Recalling firm | Alcon Research LLC |
| Firm location | Fort Worth, TX |
| Affected scope | 25,778 |
| Distribution | Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (fo… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0305-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID 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. Recalled by Alcon Research LLC. Units affected: 25,778.
Why was this product recalled? ▼
Due to incomplete seals in the pouch which provide the sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0305-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0305-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 5, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.