Z-0138-2023 Class II Ongoing
FDA device recall Z-0138-2023 was initiated by Merit Medical Systems, Inc. on Aug 3, 2022 and is designated Class II. Reason for recall: Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in… The recall status is ongoing. Affected quantity: 2894.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 2, 2022
- Initiation Date
- Aug 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2894
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France, Canada, Mexico, Puerto Rico, Chile, Reunion, Belgium, Switzerland, Japan, South Africa, Qatar, Russian Federation, Hungary, Thailand, Namibia, Colombia, New Zealand, Netherlands, Saudi Arabia, Costa Rica, Oman, Cyprus, Slovenia, Croatia, China.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0138-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026