The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0137-2023·Announced 2022-11-02

CorVocet Biopsy System recalled for needle ejection risk from component misalignment

Merit Medical Systems is recalling CorVocet Biopsy Systems due to manufacturing defects that may cause the needle to eject when triggered outside the body, risking needle stick injuries to users or patients.

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 a risk-of-harm medical device where no illnesses or injuries have been reported. Although classified as FDA Class II, the rubric requires hospitalization reports for a score of 4, which are absent. The source text explicitly states only potential harm—needle ejection may occur and may result in injury—making this a risk-of-harm product without reported injury, which scores 3.

Plain-English summary

Merit Medical Systems is recalling certain CorVocet Biopsy System units across multiple catalog codes due to component misalignment issues caused by problems with manufacturing assembly equipment. The misalignment may cause the needle to eject when triggered outside the body, posing a risk of needle stick injury to healthcare workers or patients.

The recalled biopsy systems have been distributed worldwide, including throughout the United States and numerous international markets. The recall affects 1,822 units with specific lot numbers and UDI codes identified by the FDA.

Users of the CorVocet Biopsy System should stop using affected units immediately and contact Merit Medical Systems for instructions on device return or replacement. Affected facility administrators should check their inventory against the provided lot number and UDI code list to identify recalled devices.

The recalled product

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…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Biopsy Systems
Hazard
Affected units
1,822

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/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

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 →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · needle stick injury

See all →

Similar recalls