Merit Medical CorVocet Biopsy System Recall: Needle Stick Injury Risk
Merit Medical recalls CorVocet Biopsy Systems with specific catalog codes due to misaligned components that may cause needle ejection outside the body, leading to needle stick injuries.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Merit Medical is recalling several models of CorVocet Biopsy Systems because manufacturing issues can cause needles to eject outside the body, potentially causing needle stick injuries. Affected units include specific catalog codes and lot numbers listed in the recall notice. Read more at govinfonow.com/recall/60214-merit-medical-corvocet-biopsy-system-recall-needle-stick-injury-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60214-merit-medical-corvocet-biopsy-system-recall-needle-stick-injury-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0137-2023
Cite this page
“Merit Medical CorVocet Biopsy System Recall: Needle Stick Injury Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60214-merit-medical-corvocet-biopsy-system-recall-needle-stick-injury-risk. Based on FDA recall #Z-0137-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2023%22&limit=1).
Why it’s dangerous
The biopsy systems have components that are misaligned due to manufacturing assembly equipment issues. This misalignment can cause the needle to eject when triggered outside the body, potentially leading to needle stick injuries for users or patients.
Who’s affected
Users of the CorVocet Biopsy System who own the affected catalog codes and lot numbers are at risk. Healthcare professionals and patients using these devices for biopsies may face needle stick injuries if the system malfunctions.
How to tell if you have this one
Check if your CorVocet Biopsy System has catalog codes listed in the recall notice, such as CORA1610/B, CORA1610S/B, or other specific models. Also, verify the lot numbers or UDI codes provided in the recall details.
- Brand
Merit Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0137-2023 | 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; Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192; CORA1610S/B-I2138037, I2352845/00884450476222; CORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253; CORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405; CORA1810/B-I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810, I2093993, I2114550, I2116110, I2124108, I2127451, I2137798, I2155289, I2206046, I2243065, I2263876, I2263877, I2282032, I2291981, I2297372, I2385808/00884450476116; CORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625; CORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412; CORA1815/B-I1821113, I1838444, I1855417, I1920169, I1920191, I1946564, I1952362, I1989173, I1990074, I2033176, I2070349, I2075808, I2093995, I2114555, I2116111, I2124110, I2127456, I2137805, I2170249, I2201366, I2233502, I2263885, I2269827, I2325901, I2349440/00884450477618; CORA1815S/A-H1756747, H1784863/00884450316528; CORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601; CORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429; CORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595; CORA1820S/A-H1739136, H1790841/00884450316535; CORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436; CORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571; CORA1825S/A-H1790845/00884450316542; CORA2010/A-H1784872, H1815600/00884450316443; CORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557; CORA2010S/A-H1692834, H1776070/00884450316559; CORA2015/A-H1795483/00884450316450; CORA2015/B-I1823512, I1860367, I1962715, I2140223, I2243072, I2283710, I2303054, I2330668/00884450477526; CORA2015S/A-H1697709, H1771823, H1784884, H1795484/00884450316566; CORA2020/A-H1815606/00884450316467; CORA2020/B-I1781880, I1971845, I2007291, I2228365/00884450477496; CORCA1410/A-H1639707/00884450316580; CORCA1410/B-I2244480, I2384730/00884450476284; CORCA1415/A-, H1776075/00884450316597; CORCA1415/B-I2191846, I2286700, I2318838, I2325906/00884450476314; CORCA1610/A-H1428538, H1714401/00884450316603; CORCA1610/B-I1971855, I1998714, I2114620, I2170251, I2201382, I2233505, I2318858, I2343154/00884450476338; CORCA1610S/B-I1874064, I2010416/00884450476345; CORCA1615/A-H1703701/00884450316610; CORCA1615/B-I1845903, I1888547, I1920175, I1962716, I1998860, I2103685, I2137221, I2137223, I2170252, I2237426, I2286696, I2297374, I2303056, I2330680, I2385810/00884450476352; CORCA1615S/B-I2114626, I2246748/00884450476369; CORCA1810B/A-H1718595, H1734012, H1749798, H1756750, H1771846, H1776080, H1782158, H1790850, H1800985, H1808042/00884450316627; CORCA1810B/B-I1814729, I1838323, I1843705, I1845904, I1869474, I1877911, I1888548, I1902611, I1920161, I1946561, I1946566, I1958530, I1962714, I1990098, I1990104, I1998856, I2025072, I2070266, I2070374, I2093853, I2101369, I2104884, I2114628, I2114714, I2114715, I2116109, I2124195, I2127511, I2150947, I2150948, I2150949, I2159264, I2165513, I2165514, I2201386, I2221444, I2286695, I2303061, I2330685, I2343157, I2385811/00884450476376; CORCA1810SB/A-H1733634, H1800986/00884450316801; CORCA1810SB/B-I1862927, I1920180, I2033140, I2114634, I2233507, I2303065, I2330686/00884450476383; CORCA1815B/A-H1476238, H1608916, H1714408, H1734014, H1734016, H1743880, H1749800, H1749802, H1762717, H1771848, H1776082, H1782159, H1790847, H1795487, H1807720/00884450316634; CORCA1815B/B-I1827256, I1838326, I1843709, I1845905, I1860329, I1860365, I1877914, I1888549, I1902608, I1902609, I1920165, I1920186, I1946560, I1946567, I1952368, I1958533, I1962702, I1971860, I1971861, I1990097, I1990103, I2007293, I2058398, I2061959, I2062021, I2065393, I2075813, I2075839, I2094063, I2098053, I2102664, I2105077, I2114651, I2114652, I2124197, I2127514, I2127515, I2150950, I2150952, I2159275, I2159276, I2170253, I2201393, I2217616, I2281931, I2318869, I2330533, I2330692, I2336279, I2343163, I2349439, I2357134, I2385813, I2385814/00884450476390; CORCA1815SB/A-H1714409, H1743881, H1756752, H1762715/00884450316740; CORCA1815SB/B-I1838328, I1845906, I1877918, I1958536, I2061956, I2075811, I2093850, I2094072, I2233509, I2325909, I2330694, I2399997/00884450476406; CORCA1820B/A-H1718598, H1733635, H1734019, H1749803, H1756754, H1762714, H1771883, H1776084, H1790851, H1807721/00884450316641; CORCA1820B/B-I1827257, I1845907, I1902605, I1902607, I1920166, I1946562, I1971929, I1990094, I1998850, I1998858, I2007294, I2094075, I2103689, I2114708, I2124200, I2127516, I2150980, I2159282, I2159283, I2233510, I2286679, I2343166, I2352856/00884450476413; CORCA1820SB/A-H1733637/00884450316757; CORCA1820SB/B-I2137856, I2325911/00884450476437; CORCA1825B/A-H1718603/00884450316658; CORCA1825B/B-I1946563, I2137863, I2201410, I2265757, I2325913/00884450476451; CORCA1825SB/B-I2156607/00884450476468; CORCA2010B/A-H1445217, H1703705, H1708690, H1718606, H1718607, H1749806, H1762738, H1771884, H1807725, H1815614/00884450316665; CORCA2010B/B-I18210937/I1845908, I1862929, I1874055, I1877913, I1958538, I1971927, I1990070, I2075817, I2094080, I2114709, I2127519, I2170256, I2217622, I2325922/00884450476475; CORCA2010SB/A-H1749807/00884450316771; CORCA2010SB/B-I1874058, I1902604, I1998852, I2122957, I2233511/00884450477632; CORCA2015B/A-H1624841, H1639711, H1657959, H1697713, H1708691, H1714416, H1718609, H1733639, H1734020, H1743882, H1749810, H1771851, H1776086, H1784915, H1790853, H1807727/00884450316672; CORCA2015B/B-I1827258, I1855420, I1862900, I1873128, I1874060, I1888545, I1902614, I1920156, I1952374, I1990072, I1998863, I2070355, I2080473, I2094083, I2114711, I2116112, I2124201, I2127521, I2137868, I2159284, I2191857, I2246760, I2263980, I2287299, I2303068, I2352880, I2370145/00884450477649; CORCA2015SB/A-H1662694, H1733642, H1739148, H1771853, H1776087, H1807729, H1815615/00884450316788; CORCA2015SB/B-I1827270, I1845912, I1862899, I2080472, I2170257, I2201414/00884450477656; CORCA2020B/A-H1662697, H1692861, H1708693, H1718613, H1756755, H1771854, H1776088, H1790855, H1807731/00884450316689; CORCA2020B/B, I1827272, I1845913, I1869475, I1874065, I1877915, I1971882, I1990071, I2070361, I2075814, I2114712, I2151307, I2170259, I2201416, I2330716/00884450477663; CORCA2020SB/B-I2263985, I2297377/00884450477670; | 1822 |
| Z-0138-2023 | CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB; Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704; CORA1410S/B- I2206888; CORA1415/B- I2213361; CORA1615S/B- I2114518, H1517631, H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693, I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810; CORA2010S/B- I2010414; CORCA1410S/B- I2259093; CORCA1410S/CNB- I2305358; CORCA1415S/B- I2210950; CORCA1610/CNB- I2291983; CORCA1615S/CNB- I2330683; CORCA1810SB/CNB- I2305359; CORCA1815SB/CNB- I2170254, I2205164; CORCA1820SB/CNB- I2325912; CORCA2015SB/CNB- I2318903, I2325926; CORCA2020SB/CNB- I2320880 | 2894 |
What to do — step by step
Check Product Details
Review the catalog codes and lot numbers listed in the recall notice to confirm if your device is affected.
Contact Merit Medical
Reach out to Merit Medical Systems for further assistance or to confirm if your specific model is included in the recall.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 42 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0137-2023 (August 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0137-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.