Recall Z-1129-2026
Merit Medical Systems, Inc. · initiated December 4, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Codes / 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
Reason for recall
Inflation device handle may detach from the syringe during procedure.
FDA-determined cause: Process control
Action taken
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 RESPONSE@merit.com within seven (7) calendar days
Details
- Recall number
- Z-1129-2026
- Initiated
- December 4, 2025
- Posted by FDA
- January 16, 2026
- Product code
- OEQ – Angiography/Angioplasty Kit
- Quantity
- 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…
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1123-2026 Class II | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers:…Inflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1124-2026 Class II | Allwell Inflation Device, for angiographic use REF: IS-30-AInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1125-2026 Class II | Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261Inflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1126-2026 Class II | Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C…Inflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1127-2026 Class II | Merit Medical , Custom Manifold Kit REF: K09-13203AInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1128-2026 Class II | Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922BInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |