“Merit Medical Recalls Eye Solution Kits Due to Sterility Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/49000-merit-medical-systems-inc-recalls-merit-convenience-kits-containing-cytosol. Based on FDA recall #D-040-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-040-2013%22&limit=1).
Merit Medical Systems, Inc voluntarily recalled Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution on Feb. 24, 2006, according to the FDA. The kits may lack sterility assurance due to potential endotoxin contamination. Owners should contact the company for a refund.
How to tell if you have it
Brand: Merit Medical Systems
Product: Merit Convenience Kits with Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle
NDC: 23731-8100-8
Part Number: 8118
Lot codes: All lot numbers
Quantity: 2470 kits
Distribution: Connecticut, Maryland, Ohio, and South Carolina
The hazard
The procedure kits contain a balanced salt solution that may be contaminated with endotoxins. This lack of assurance of sterility poses a risk to users.
Context
GovInfoNow's records show Merit Medical Systems, Inc has had 37 other recalls since Sept. 20, 2017. Recent brand recalls include the Embosphere 500-700 Micrometer Syringe (Aug. 10, 2026) and the Splashwire Hydrophilic Guide Wire (May 8, 2026). Other recent recalls of similar products include Geri-Care Eye Drops (March 25, 2026), Clear Eyes Eye Drops (July 29, 2026), and TRP Gentle Eyes Lubricant Eye Drops (Aug. 20, 2026).
How to tell if you have this one
Check if you have a Merit Convenience Kit containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle. Look for NDC 23731-8100-8 and Part Number 8118 on the packaging.
Brand
Merit Medical Systems
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using the kits immediately
Do not use any Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, Part Number 8118, due to sterility concerns.
Contact your supplier or distributor
Reach out to the vendor where you purchased the kits to arrange for a refund or replacement as per the recall instructions.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “Connecticut, Maryland, Ohio, and South Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, Maryland, Ohio, South Carolina.
Recall timeline
FDA terminated this recall 7 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-040-2013 (February 24, 2006) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-040-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.