INNOVATIVE TOMOGRAPHY PRODUCT GMBH: Medical Device Recall in 2021 - (Recall #: Z-2164-2021)

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:

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 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US

Product Classification:

Class II

Date Initiated: April 21, 2021

Date Posted: August 4, 2021

Recall Number: Z-2164-2021

Event ID: 88213

Reason for Recall:

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Status: Ongoing

Product Quantity: N/A

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated