Reported Nov 2, 2022 · Ongoing
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/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
CORA1410/BCORA1410S/BCORA1415/BCORA1615S/BCORA2010S/BCORCA1410S/BCORCA1410S/CNBCORCA1415S/BCORCA1610/CNBCORCA1615S/CNBCORCA1810SB/CNBCORCA1815SB/CNBCORCA1820SB/CNBCORCA2015SB/CNBCORCA2020SB/CNB
- Lot codes and dates
15 of 15 products
Products covered by this recall # Product as published 1 Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704 2 CORA1410S/B- I2206888 3 CORA1415/B- I2213361 4 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 5 CORA2010S/B- I2010414 6 CORCA1410S/B- I2259093 7 CORCA1410S/CNB- I2305358 8 CORCA1415S/B- I2210950 9 CORCA1610/CNB- I2291983 10 CORCA1615S/CNB- I2330683 11 CORCA1810SB/CNB- I2305359 12 CORCA1815SB/CNB- I2170254, I2205164 13 CORCA1820SB/CNB- I2325912 14 CORCA2015SB/CNB- I2318903, I2325926 15 CORCA2020SB/CNB- I2320880 - Amount recalled
- 2894
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
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.
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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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