Z-1129-2026Class II

Allwell Angioplasty Pack REF: IS-30-B1/B

Name: Z-1129-2026 Allwell Angioplasty Pack REF: IS-30-B1/B
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 Angioplasty Pack REF: IS-30-B1/B 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-1129-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-04
Posted: 2026-01-16
Recalling firm: Merit Medical Systems, Inc.
Product: Allwell Angioplasty Pack REF: IS-30-B1/B
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: 328000 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: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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2026
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)