# FDA recall Z-1126-2026

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2025-12-04.

## Product

Merit Medical , Custom Inflation Kit  REF: K05-00761F	K05-01717B	K05-02080D	K05-02090C	K05-02221	K05-02338	K05-02470	K05-02954	K05-03094A	K05T-00380C	K05T-01674B	K05T-01863	K05T-01915	K05T-01920F	K05T-01955	K05T-02138	K05T-02138A	K05T-02272G	K05T-02272H	K05T-02533	K05T-03153	K05T-03201

## Reason for recall

Inflation device handle may detach from the syringe during procedure.

## 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 Mar

## Key facts

- **Recall number:** Z-1126-2026
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-04
- **Report date:** 2026-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1126-2026

## Citation

> AI Analytics. FDA recall Z-1126-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1126-2026. Source: US FDA. Licensed CC0.

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