Recall Z-1124-2026
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 Inflation Device, for angiographic use REF: IS-30-A
Codes / 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
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-1124-2026
- Initiated
- December 4, 2025
- Posted by FDA
- January 16, 2026
- Product code
- OEQ – Angiography/Angioplasty Kit
- 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…
- 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-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 |
| Z-1129-2026 Class II | Allwell Angioplasty Pack REF: IS-30-B1/BInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |