Z-0889-2017Class II

Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic...

Name: Z-0889-2017 Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic...
Creator: Medtronic
Published: 2016-10-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-10-04 / Terminated / root cause: manufacturing process

FDA source

Medtronic began a recall of Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of... on 2016-10-04. FDA classified it as Class II and gives the reason as "Product sterility is compromised due to breach of the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0889-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-04
Posted: 2016-12-22
Terminated: 2018-08-08
Recalling firm: Medtronic, Inc.
Product: Covidien 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 code: FEI Instrument, Special Lens, For Endoscope
Reason for recall: Product sterility is compromised due to breach of the sterile barrier
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices will be reworked. Questions or concerns, contact your Medtronic representative or customer service at 800-882-5878.
Quantity in commerce: 1,293,169 systems
Distribution: 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
Product codes and lots: Lots beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0889-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0889-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0890-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code FEI

K062779Class IIDefogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)New Wave Surgical Corporation / cleared 2006-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)