CorVocet Biopsy System/Catalog Code: CORA1610/B — Class II medical device recall Z-0137-2023
Ongoing recall by Merit Medical Systems, Inc., reported 2022-11-02, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment,
| Recall number | Z-0137-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2022-08-03 |
| Classified | 2022-10-27 |
| Reported by FDA | 2022-11-02 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CN, CO, CR, CY, DE, DK, ES, FI, FR, GB, HR, HU, IT, JO, JP, MX, NL, NO, NZ, OM, QA, SA, SE, SI, TH, ZA |
| Quantity | 1,822 |
| UPC / GTIN / UDI-DI | 00884450316405, 00884450316412, 00884450316429, 00884450316436, 00884450316443, 00884450316450, 00884450316467, 00884450316528, 00884450316535, 00884450316542, 00884450316559, 00884450316566, 00884450316580, 00884450316597, 00884450316603, 00884450316610, 00884450316627, 00884450316634, 00884450316641, 00884450316658, 00884450316665, 00884450316672, 00884450316689, 00884450316740, 00884450316757 and 35 more |
| Model numbers | CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A and 33 more |
Product
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B
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 user or patient needle stick injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0137-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.