Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Allwell Angioplasty Pack REF: IS-30-B1/B
Why it was recalled
Inflation device handle may detach from the syringe during procedure.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
UDI:00884450653388/ Lot: I2563105 I2563106 I2565007 I2598114 I2598131 I2607891 I2612499 I2618005 I2623057 I2632527 I2632528 I2639728 I2661908 I2669772 I2669774 I2827091 I2827094 I2844360 I2844361 I2897482 I2897483 I2897484 I2897485 I2924663 I2972425 I2972426 I2972427 I2972428 I2999054 I3014683 I3030198 I3048363 I3055799 I3080949 I3089230 I3099150 I3110034 I3129711 I3129712 I3161408 I3268359 I3268361 I3268362
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
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 record
- Recalling firm
- Merit Medical Systems, Inc.
- Product type
- Devices
- Recall number
- Z-1129-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Origin
- South Jordan, UT
- Recall initiated
- 2025-12-04
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1129-2026 · Source: openFDA enforcement.