# FDA recall Z-1123-2026

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

## Product

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL  Reference Numbers: ENDO-AN2030/B	IN4130/CNK	IN4130/H	IN4130/JPH	IN4130/K	IN4130/KRK	IN4130/L	IN4130/T	IN4230/JPH	IN4230/K	IN4330/CNK	IN4330/K	IN4352/K	IN4430/K	IN4530/CNK	IN4530/K	IN4530/T	IN4802/K	IN4802/T	IN4852/K	IN4901/A	IN4902/A	IN4903/A	IN4904/A	IN4905/A	IN4906/A	IN4907/A	IN4908	IN4909	IN4910	IN4911/A	IN4912	IN4913/A	IN4914/A	IN4915	IN4916/A	IN4917/A	IN4918/A	IN4919/A

## 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-1123-2026
- **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-1123-2026

## Citation

> AI Analytics. FDA recall Z-1123-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1123-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*