Z-1124-2026Class II

Allwell Inflation Device, for angiographic use REF: IS-30-A

Name: Z-1124-2026 Allwell Inflation Device, for angiographic use REF: IS-30-A
Creator: Merit Medical Systems, Inc.
Published: 2025-12-04
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2025-12-04 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Allwell Inflation Device, for angiographic use REF: IS-30-A on 2025-12-04. FDA classified it as Class II and gives the reason as "Inflation device handle may detach from the syringe during procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1124-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-04
Posted: 2026-01-16
Recalling firm: Merit Medical Systems, Inc.
Product: Allwell Inflation Device, for angiographic use REF: IS-30-A
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: Inflation device handle may detach from the syringe during procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On December 4, 2025 Merit Medical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. Merit asked consignees to take the following actions: 1. Please read and understand the recall notification. 2. Should the handle detach during use and the balloon not completely deflate, pull the handle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast 3. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4. Please fill out, scan, and email the completed Customer Response Form to Customer Service at [email protected] within seven (7) calendar days
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1124-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1123-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1124-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1125-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1126-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1127-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1128-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1129-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)