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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84443

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 13, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CooperSurgical, Inc.

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

1 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 1

ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

Z-0798-2020
Recall number
Z-0798-2020
Initiated
December 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
CooperSurgical, Inc.
Quantity
460

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).

Code information

Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020

Distribution pattern

US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY. OUS: None