Imactis: Medical Device Recall in 2020 - (Recall #: Z-0838-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

Product Classification:

Class II

Date Initiated: August 1, 2019

Date Posted: January 29, 2020

Recall Number: Z-0838-2020

Event ID: 84460

Reason for Recall:

The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.

Status: Ongoing

Product Quantity: 122 kits

Code Information:

Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22

Distribution Pattern:

US: WI & IL

Voluntary or Mandated:

Voluntary: Firm initiated