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Moderate riskFDA DeviceClass II

Merit Medical Allwell Inflation Device recalled for detachable handle during angiographic procedures

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.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

  1. Stop using affected Allwell Inflation Devices immediately
  2. Check your device lot number against the recall list
  3. Contact Merit Medical Systems for instructions on device return or replacement
  4. Notify your facility's medical device coordinator if you use this product
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allwell Inflation Device, for angiographic use REF: IS-30-A
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
173,645 units
Illnesses reported
None reported
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Classification
Class II
Recall number
Z-1124-2026

In the FDA's words

Description
Allwell Inflation Device, for angiographic use REF: IS-30-A Inflation device handle may detach from the syringe during procedure. UDI: 00884450653500 /Lot: I2559701 I2563344 I2567488 I2578111 I2593681 I2593683 I2603907 I2617788 I2622059 I2628990 I2653159 I2657407 I2853633 I2887859 I2887860 I2892046 I2917191 I2921522 I2927924 I2933535 I2989185 I2989187 I3027377 I3027378 I3037369 I3085686 I3085687 I3103552 I3118248 I3118249 I3154769 I3186052 I3186054 I3186058 I3214004 I3245239 I3245240 I3248078 I3282794 Distribution: 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 quantity: 173,645 units
Hazard
Inflation device handle may detach from the syringe during procedure.

7 products in this recall

Merit Medical inflation devices and kits recalled for handle detachment

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Merit Medical

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