BIOPSYBELL S.R.L.: Medical Device Recall in 2021 - (Recall #: Z-1639-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK

Product Classification:

Class II

Date Initiated: March 22, 2021

Date Posted: May 26, 2021

Recall Number: Z-1639-2021

Event ID: 87696

Reason for Recall:

Products labeled as sterile were distributed, but may not have been sterilized.

Status: Terminated

Product Quantity: 330 units

Code Information:

LOT: 2001201, 2003859, 20051288, 20061419

Distribution Pattern:

US Nationwide distribution in the states MS and KY.

Voluntary or Mandated:

Voluntary: Firm initiated