Merit Medical Prelude SNAP Splittable Sheath Introducer Recall: 7F vs 10F Packaging Error
Merit Medical recalls Prelude SNAP Splittable Sheath Introducer (REF: PLSX-1:10F) due to potential packaging error where 7F sheaths are shipped as 10F. This may cause incorrect use in medical procedures.
Lower-risk recall
There is a potential that 7F sheaths are packaged as 10F sheaths.
Contact the company
What happened, in plain English
Merit Medical is recalling their Prelude SNAP Splittable Sheath Introducer (size 10F) because it might be packaged incorrectly as 10F when it's actually a 7F sheath. This could lead to improper use during medical procedures if the wrong size is used. Read more at govinfonow.com/recall/62261-merit-medical-prelude-snap-splittable-sheath-introducer-recall-7f-vs.
Source Summary by GovInfoNow · govinfonow.com/recall/62261-merit-medical-prelude-snap-splittable-sheath-introducer-recall-7f-vs · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2238-2021
Cite this page
“Merit Medical Prelude SNAP Splittable Sheath Introducer Recall: 7F vs 10F Packaging Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62261-merit-medical-prelude-snap-splittable-sheath-introducer-recall-7f-vs. Based on FDA recall #Z-2238-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2238-2021%22&limit=1).
Why it’s dangerous
The recall addresses a packaging error where 7F sheaths are mistakenly labeled as 10F. Using the wrong size could lead to improper placement of medical devices during procedures, potentially causing complications.
Who’s affected
Healthcare professionals who use this device for cardiac procedures may be affected. Patients receiving procedures with this device could be at risk if the incorrect size is used.
How to tell if you have this one
Check for the product code REF: PLSX-1010, size 10F, standard length 13 cm, CE0344, and sterile packaging. The lot number I2067768 is also associated with this recall.
- Brand
Merit Medical Systems- Product
Merit Medical Systems, Inc. recalls Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2238-2021 | Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.; Lot #I2067768 | 760 units |
| Z-2239-2021 | Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.; Lot # I2059849 | 760 UNITS |
What to do — step by step
Check Product Details
Verify the product code, size, and lot number to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed in 29 states.
FDA distribution: “US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Vermont, Virginia, Wisconsin.
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.
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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-2238-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2238-2021 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.