BIOPSYBELL S.R.L.: Medical Device Recall in 2021 - (Recall #: Z-1637-2021)

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:

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD

Product Classification:

Class II

Date Initiated: March 22, 2021

Date Posted: May 26, 2021

Recall Number: Z-1637-2021

Event ID: 87696

Reason for Recall:

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

Status: Terminated

Product Quantity: 625 units

Code Information:

LOT: 19102741, 200127, 2001246, 2101242

Distribution Pattern:

US Nationwide distribution in the states MS and KY.

Voluntary or Mandated:

Voluntary: Firm initiated