Merit Medical Flex-Neck Catheter Repair Kit: Design Verification Product Recalled
Merit Medical recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A distributed for design verification testing. This product was not intended for customer use.
Recall notice
Product that was built for design verification testing was inadvertently distributed to customers.
Contact the company
What happened, in plain English
Merit Medical is recalling a specific repair kit for catheters because it was mistakenly sent to customers instead of being used for internal testing. This kit should not be used as it was built for design verification, not actual medical use. Read more at govinfonow.com/recall/58885-merit-medical-flex-neck-catheter-repair-kit-design-verification-product.
Source Summary by GovInfoNow · govinfonow.com/recall/58885-merit-medical-flex-neck-catheter-repair-kit-design-verification-product · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1352-2023
Cite this page
“Merit Medical Flex-Neck Catheter Repair Kit: Design Verification Product Recalled.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58885-merit-medical-flex-neck-catheter-repair-kit-design-verification-product. Based on FDA recall #Z-1352-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2023%22&limit=1).
Why it’s dangerous
This repair kit was designed for internal testing to verify product design, not for actual medical use. Distributing it to customers means it may not meet medical safety standards. Using it could lead to improper catheter repairs.
Who’s affected
Healthcare professionals who received this repair kit for catheter repairs are affected. Patients using the kit for medical purposes are at risk of using an unverified product.
How to tell if you have this one
Check for the product name 'Flex-Neck Catheter External Repair Kit', catalog number CE-1400/A, and lot number H2586496. This kit was distributed for design verification testing and not intended for customer use.
- Brand
Merit Medical Systems- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number CE-1400/A and lot number H2586496 to confirm if you have the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, Michigan, Ohio, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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 #Z-1352-2023 (February 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1352-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.