CooperSurgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0798-2020)

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:

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.

Product Classification:

Class II

Date Initiated: December 13, 2019

Date Posted: January 22, 2020

Recall Number: Z-0798-2020

Event ID: 84443

Reason for Recall:

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

Status: Terminated

Product Quantity: 460

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

Voluntary or Mandated:

Voluntary: Firm initiated