Medtronic: Medical Device Recall in 2016 - (Recall #: Z-0890-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

Product Classification:

Class II

Date Initiated: October 4, 2016

Date Posted: December 28, 2016

Recall Number: Z-0890-2017

Event ID: 75301

Reason for Recall:

Product sterility is compromised due to breach of the sterile barrier

Status: Terminated

Product Quantity: 230 systems

Code Information:

Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363 00Z2364 00Z2365 00Z2366 00Z2421 00Z2425 00Z2430 00Z2431 00Z2460 00Z2493 00Z2534 00Z2535 000Z2544 00Z5000B 00Z5001B GYNKIT2

Distribution Pattern:

Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated