FDA-Device2026-01-28Class IIPROCESSING DEFECT
Merit Medical Allwell Inflation Device recalled for detachable handle during angiographic procedures
What this means
Merit Medical Systems is recalling the Allwell Inflation Device (model IS-30-A) used in angiographic procedures because the handle may detach from the syringe during use. This could compromise the procedure and patient safety. The recall affects specific lot numbers distributed worldwide.
- Stop using affected Allwell Inflation Devices immediately
- Check your device lot number against the recall list
- Contact Merit Medical Systems for instructions on device return or replacement
- Notify your facility's medical device coordinator if you use this product
The agency's original wording
Hazard
Inflation device handle may detach from the syringe during procedure.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
Affected count
173,645 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Allwell Inflation Device, for angiographic use REF: IS-30-A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2026More Merit Medical recalls
- FDA-Device2026-06-24Merit Medical Splashwire Hydrophilic Guide Wire recalled for unsealed pouches
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