The Recall Desk
HighFDA (Devices)·Z-1648-2021·Announced 2021-05-26

Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

What this means for you

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: The recall involves a medical device labeled as sterile that may not be, creating a risk of infection. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no illnesses or injuries are explicitly stated in the source.

Plain-English summary

Biopsybell S.R.L. is recalling 40 units of 10G coaxial cannulas with Tuohy connection (Code INTVM-CC, Lot 20102495). The recall was initiated because the products were labeled as sterile but may not have been sterilized.

The affected units were distributed nationwide in the United States, specifically within the states of Mississippi and Kentucky. No specific dates of distribution or number of affected patients are provided in the source text.

Consumers and healthcare facilities should stop using the affected cannulas and contact Biopsybell S.R.L. for further instructions or a return.

The recalled product

Product
10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
Manufacturer
BIOPSYBELL S.R.L.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
40

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 (1)

  • LOT: 20102495

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 19 recalled by BIOPSYBELL S.R.L. 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 19 products in this recall →

Related recalls

Same manufacturer · BIOPSYBELL S.R.L.

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Same hazard · infection risk

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