Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported November 14, 2012
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Merit Medical Systems, Inc recalled Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Singl… - a critical-severity action.
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Singl… was recalled by Merit Medical Systems, Inc in November 14, 2012. Reason: Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with…. Check the official notice for the remedy. Verify recall #D-040-2013 with the FDA Drug before acting.
The recall
Merit Medical Systems, Inc issued this critical-severity FDA Drug recall-Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with….
- Critical
- severity level
- Class I
- classification
- November 14, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-040-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-040-2013) was formally reported on November 14, 2012, with the manufacturer initiating the action on February 24, 2006. It is classified under Critical severity (Class I), with a current status of Terminated. Merit Medical Systems, Inc is listed as the recalling firm, operating out of South Jordan, UT. Federal records list the affected scope as 2470 kits.
The documented reason for this recall is: Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. Distribution data in the federal record shows the product reached: Connecticut, Maryland, Ohio, and South Carolina.. 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2470 kits
Related Recalls
6
0 from same agency
Product description
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Reason for recall
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-040-2013 |
| Date reported | November 14, 2012 |
| Date initiated | February 24, 2006 |
| Recalling firm | Merit Medical Systems, Inc |
| Firm location | South Jordan, UT |
| Affected scope | 2470 kits |
| Distribution | Connecticut, Maryland, Ohio, and South Carolina. |
Profile values are sourced directly from the official FDA Drug 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 (D-040-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug 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? ▼
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.. Recalled by Merit Medical Systems, Inc. Units affected: 2470 kits.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2012. Severity: Critical. Recall number: D-040-2013.
Where was the recalled product distributed? ▼
Distribution: Connecticut, Maryland, Ohio, and South Carolina..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-040-2013) against your product. Visit the official FDA Drug 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 Drug, reported November 14, 2012. 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.