Exact FDA event identifier

Event 75301

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 04, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medtronic

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0889-2017

Recall number: Z-0889-2017
Initiated: October 04, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medtronic
Quantity: 1,293,169 systems

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterility is compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product sterility is compromised due to breach of the sterile barrier

Code information

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

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

device · product 2 of 2

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

Z-0890-2017

Recall number: Z-0890-2017
Initiated: October 04, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medtronic
Quantity: 230 systems