Merit Medical Prelude Short Sheath Introducer Recall: Incorrect Dilator Risk
Merit Medical recalls Prelude Short Sheath Introducer (REF: PSS-6F-4-018MT) due to potential incorrect dilator in package. This may cause complications during medical procedures. Affected units were sold with specific model and lot numbers.
Lower-risk recall
There is a potential that a package sheath contains an incorrect dilator.
Contact the company
What happened, in plain English
Merit Medical is recalling their Prelude Short Sheath Introducer (model PSS-6F-4-018MT) because some packages might contain the wrong dilator. This could lead to complications during medical procedures if used incorrectly. Read more at govinfonow.com/recall/62181-merit-medical-prelude-short-sheath-introducer-recall-incorrect-dilator-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62181-merit-medical-prelude-short-sheath-introducer-recall-incorrect-dilator-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2243-2021
Cite this page
“Merit Medical Prelude Short Sheath Introducer Recall: Incorrect Dilator Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62181-merit-medical-prelude-short-sheath-introducer-recall-incorrect-dilator-risk. Based on FDA recall #Z-2243-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2243-2021%22&limit=1).
Why it’s dangerous
The recall is for a potential incorrect dilator in the package. If the wrong dilator is used during a medical procedure, it could cause complications. This is a manufacturing issue that affects the device's safety.
Who’s affected
Healthcare professionals using this medical device for procedures are most at risk. Patients receiving the device during medical treatments may be affected if the incorrect dilator is used.
How to tell if you have this one
Check for the model number PSS-6F-18MT on the device. The product was sold with specific lot number H2069291 and was manufactured with sterile packaging.
- Brand
Merit Medical- Product
Merit Medical Systems, Inc. recalls MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46- Category
Medical device
What to do — step by step
Check Device Model
Look for the model number PSS-6F-4-018MT on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Hawaii, Idaho, Kansas, Minnesota, Missouri, Texas, Utah.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device safe to use?
The recall indicates a potential issue with the dilator in the package, so it is not recommended to use until the recall is addressed.
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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-2243-2021 (July 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2243-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.