Reported Nov 2, 2022 · Ongoing

CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B,…

Merit Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416

Is this the product you have?

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

Lot codes and dates: 60 of 60 products
Products covered by this recall
# Barcodes Product as published
1 00884450476192 Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192
2 00884450476222 CORA1610S/B-I2138037, I2352845/00884450476222
3 00884450476253 CORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253
4 00884450316405 CORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405
5 00884450476116 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
6 00884450477625 CORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625
7 00884450316412 CORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412
8 00884450477618 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
9 00884450316528 CORA1815S/A-H1756747, H1784863/00884450316528
10 00884450477601 CORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601
11 00884450316429 CORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429
12 00884450477595 CORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595
13 00884450316535 CORA1820S/A-H1739136, H1790841/00884450316535
14 00884450316436 CORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436
15 00884450477571 CORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571
16 00884450316542 CORA1825S/A-H1790845/00884450316542
17 00884450316443 CORA2010/A-H1784872, H1815600/00884450316443
18 00884450477557 CORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557
19 00884450316559 CORA2010S/A-H1692834, H1776070/00884450316559
20 00884450316450 CORA2015/A-H1795483/00884450316450
Page 1 of 3
Amount recalled: 1822

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B…

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

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53 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`00884450476192`	Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192
2	`00884450476222`	CORA1610S/B-I2138037, I2352845/00884450476222
3	`00884450476253`	CORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253
4	`00884450316405`	CORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405
5	`00884450476116`	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
6	`00884450477625`	CORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625
7	`00884450316412`	CORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412
8	`00884450477618`	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
9	`00884450316528`	CORA1815S/A-H1756747, H1784863/00884450316528
10	`00884450477601`	CORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601
11	`00884450316429`	CORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429
12	`00884450477595`	CORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595
13	`00884450316535`	CORA1820S/A-H1739136, H1790841/00884450316535
14	`00884450316436`	CORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436
15	`00884450477571`	CORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571
16	`00884450316542`	CORA1825S/A-H1790845/00884450316542
17	`00884450316443`	CORA2010/A-H1784872, H1815600/00884450316443
18	`00884450477557`	CORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557
19	`00884450316559`	CORA2010S/A-H1692834, H1776070/00884450316559
20	`00884450316450`	CORA2015/A-H1795483/00884450316450