The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0138-2023·Announced 2022-11-02

CorVocet Biopsy System recall due to potential unintended needle ejection

Merit Medical Systems is recalling 2,894 CorVocet Biopsy Systems because misaligned components may cause the needle to eject unexpectedly when triggered outside the body, risking needle stick injuries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (needle stick injury from unintended needle ejection) where no injuries have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Merit Medical Systems, Inc. is recalling 2,894 units of the CorVocet Biopsy System due to a manufacturing defect. The CorVocet Biopsy System is a medical device used to obtain tissue samples during diagnostic procedures.

The systems contain components that are misaligned due to an issue with the manufacturing assembly equipment. This misalignment may cause the needle to eject when triggered outside the patient's body, creating a risk of needle stick injuries to healthcare workers or patients.

Affected devices have been distributed worldwide, including throughout the United States and multiple countries. The FDA classified this recall as Class II. For specific lot numbers, distribution details, and manufacturer instructions, refer to FDA recall Z-0138-2023.

The recalled product

Product
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
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Biopsy / Needle Systems
Hazard
Affected units
2,894

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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