Z-0798-2020Class II

ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee...

Name: Z-0798-2020 ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee...
Creator: CooperSurgical, Inc.
Published: 2019-12-13
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2019-12-13 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a... on 2019-12-13. FDA classified it as Class II and gives the reason as "Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0798-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-13
Posted: 2020-01-10
Terminated: 2021-05-11
Recalling firm: CooperSurgical, Inc.
Product: 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 code: HIH Hysteroscope (And Accessories)
Reason for recall: Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Root cause tag: packaging
FDA root cause: Other
Action: On December 13, 2019 the firm sent out letters via Fed-Ex stating the following: URGENT: MEDICAL DEVICE RECALL COOPERSURGICAL ENDOSEE CANNULA Dear Valued CooperSurgical Customer, CooperSurgical is issuing a Medical Device Recall for two lot numbers (268748 & 269360) of its ENDOSEE Advance Cannula (CooperSurgical part number: ESPX5) (the Product), because the finished seal (opposite the chevron seal) of the sterile pouch may be compromised, thereby increasing the risk of infection. The Product is an Ethylene Oxide (ETO) sterilized, single-use, disposable cannula, which is sold in 5 Units/box. Each Unit contains an individually wrapped cannula and an individually pouched endometrial suction pipet curette. The compromised seals were detected during a complaint investigation. No adverse events have been reported to CooperSurgical due to this potential issue. This recall affects 2,285 units of the 2 lot numbers shown above, which were manufactured in April and August 2019. We have identified the root cause, and a corrective action has been initiated to prevent future recurrence. Our records indicate that you have purchased the affected Product from CooperSurgical. As indicated in the Instructions-for-Use (IFU), each package should be handled with care and inspected for damage, including the seal area, prior to use. A Product is acceptable for use if it is visually confirmed that the pouchs seal is intact. Please discontinue use of and quarantine Products with any packaging irregularities, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to
Quantity in commerce: 460
Distribution: 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
Product codes and lots: Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0798-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0798-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10

Product code HIH

K190639Class IIEndosee SystemCooperSurgical, Inc. / cleared 2019-05-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)