The Recall Desk
HighFDA (Devices)·Z-2164-2021·Announced 2021-08-04

Semi-automatic Biopsy Needles Recalled Due to Sterilization Defect

INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling semi-automatic biopsy needles because labeled sterile units may not have been adequately sterilized. Affected devices distributed in California should not be used.

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: Inadequate sterilization of an invasive medical device creates serious infection risk. With no reported injuries and FDA Class II classification, this meets the criteria for High severity as a risk-of-harm product.

Plain-English summary

INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling multiple sizes of semi-automatic biopsy needles marketed as sterile and ethylene oxide sterilized. The affected article numbers include BIM 18/10, BIM 18/15, BIM 18/20, BIM 16/10, BIM 16/15, BIM 16/20, BIM 14/10, BIM 14/15, and BIM 14/20 in various lengths and gauges.

The FDA determined that these needles may not have been adequately sterilized despite their sterile labeling, creating a risk of infection if used in medical procedures.

The affected devices were distributed in California. Specific lot numbers for each article size have been identified by the manufacturer. Healthcare providers and facilities with these devices should stop using them immediately and contact INNOVATIVE TOMOGRAPHY PRODUCT GMBH for instructions on replacement or return procedures.

The recalled product

Product
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter
Manufacturer
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Category
Medical Device — Biopsy Needle
Hazard
  • sterilization-failure
  • infection-risk

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 (14)

  • Affected Lot Numbers: BIM 18/10: LOT: 4918
  • BIM 18/15: LOT: 4017
  • 4918
  • 4719
  • BIM 18/20: LOT: 4017
  • BIM 16/10: LOT: 4918
  • 1119
  • 1219
  • BIM 16/15: LOT: 4918
  • BIM 16/20: LOT: 4918
  • BIM 14/10: LOT: 4918
  • 3019
  • BIM 14/15: LOT: 4918
  • BIM 14/20: LOT: 4918

Distribution

Distributed nationwide across the United States.

Related recalls

Same category