Allwell Inflation Device recall
Allwell Inflation Device, for angiographic use REF: IS-30-A
Why was Allwell Inflation Device recalled?
Inflation device handle may detach from the syringe during procedure.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Allwell Inflation Device, for angiographic use REF: IS-30-A
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 173,645 units
- 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.
- Recall date
- January 28, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)