The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0643-2024·Announced 2024-01-17

Bard Mission Biopsy Instrument Kits Recalled for Improper Needle-Cannula Fit

Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.

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 with no reported illnesses or injuries. The hazard is a dimensional malfunction that creates a risk of tissue injury and procedural complications, but no actual harm has been reported. Per the recall rubric, risk-of-harm products without reported injuries score at most 3 (High).

Plain-English summary

Bard Peripheral Vascular Inc is recalling Bard Mission Disposable Core Biopsy Instrument Kits. These kits are used to obtain tissue samples during core needle biopsy procedures. Multiple models are included in the recall, covering various needle gauges (14G through 20G) and lengths (10 to 25 cm).

The recall was issued because the internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle. Additionally, the length of the cannula may exceed the stated length on the product label. As a result, the biopsy needle may not fit properly into the coaxial cannula.

When the needle does not fit properly into the cannula, access to the target tissue may be prevented. This could lead to tissue injury and may result in the need for longer or repeat procedures. Over 1.2 million units have been distributed worldwide, including throughout the United States.

The recalled product

Product
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission…
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Diagnostic / Biopsy Instruments
Hazard
Affected units
1,243,937

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)

  • REF/UDI-DI/Lot (Expiration Date): 1410MSK/ 00801741142543/ 0001418630(05/28/24)
  • 0001429851(07/28/24)
  • 0001433778(08/28/24)
  • 0001441794(10/28/24)
  • 0001443076(10/28/24
  • 0001446454(11/28/24
  • 0001451131(01/28/25
  • 0001452840(01/28/25
  • 0001463142(03/28/25
  • 0001468867(04/28/25
  • 0001475757(06/28/25
  • 0001481508(07/28/25
  • 0001485193(08/28/25
  • 0001487094(08/28/25
  • 0001488512(08/28/25
  • 0001491080(09/28/25
  • 0001491583(09/28/25
  • 0001498859(11/28/25
  • 0001502349(12/28/25)
  • 1416MSK/ 00801741142550/0001402196(01/28/24)

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

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