Merit Medical basixALPHA Inflation Device 30 atm/bar 20 mL: Handle may separate during use
Merit Medical recalls basixALPHA Inflation Devices 30 atm/bar 20 mL due to risk of handle separation during use. Affected units have specific catalog numbers and lot numbers listed in the recall notice.
Use caution until it’s fixed
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Contact the company
What happened, in plain English
Merit Medical is recalling certain basixALPHA Inflation Devices that may have a handle that separates from the device when withdrawn. This could lead to improper balloon inflation during medical procedures, potentially causing injury. Read more at govinfonow.com/recall/62355-merit-medical-basixalpha-inflation-device-30-atm-bar-20-ml.
Source Summary by GovInfoNow · govinfonow.com/recall/62355-merit-medical-basixalpha-inflation-device-30-atm-bar-20-ml · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2166-2021
Cite this page
“Merit Medical basixALPHA Inflation Device 30 atm/bar 20 mL: Handle may separate during use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62355-merit-medical-basixalpha-inflation-device-30-atm-bar-20-ml. Based on FDA recall #Z-2166-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2021%22&limit=1).
Why it’s dangerous
The handle can separate from the inflation device when it is withdrawn, which may cause the balloon to deflate unexpectedly. This could lead to improper inflation of the angioplasty balloon during medical procedures, potentially causing injury to the patient.
Who’s affected
Medical professionals using the device for angioplasty procedures are most at risk. Patients receiving these devices during procedures may also be affected if the device malfunctions.
How to tell if you have this one
Check for catalog numbers IN3130, IN3152, or IN3302 with specific lot numbers listed in the recall notice. The product is used to inflate and deflate angioplasty balloons.
- Brand
Merit Medical- Category
Medical device
What to do — step by step
Check Device Lot Number
Look for lot numbers on the device packaging or label: H1862928, H1896261, H1923761, H1929106, H1939255, H1966485, H1978295, H2068264, H2073193, H2073247, H2077173, and others as listed in the recall.
Contact Merit Medical
Reach out to Merit Medical Systems for further assistance or to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 31 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.9 years 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-2166-2021 (June 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2166-2021 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.