Cooper Surgical Endosee Cannula Recall: Unsealed Pouches Risk
Cooper Surgical recalls Endosee Cannula (ESPX5) with potential unsealed pouches in two lots. Affected units may have pouches that could leak, causing contamination. Stop using and contact for replacement.
Lower-risk recall
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Contact the company
What happened, in plain English
Cooper Surgical is recalling Endosee Cannula (model ESPX5) because some units have pouches that might not seal properly. This could lead to contamination during medical procedures. Affected units are in two specific lots with expiration dates. Read more at govinfonow.com/recall/66321-cooper-surgical-endosee-cannula-recall-unsealed-pouches-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66321-cooper-surgical-endosee-cannula-recall-unsealed-pouches-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0798-2020
Cite this page
“Cooper Surgical Endosee Cannula Recall: Unsealed Pouches Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66321-cooper-surgical-endosee-cannula-recall-unsealed-pouches-risk. Based on FDA recall #Z-0798-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0798-2020%22&limit=1).
Why it’s dangerous
The cannula's pouches may not seal correctly, potentially leaking during medical procedures. This could cause contamination of the procedure site or medical equipment. The risk is low but requires careful handling.
Who’s affected
Medical professionals using the Endosee Cannula for procedures are most at risk. Patients receiving the cannula during procedures could be affected if the pouch leaks.
How to tell if you have this one
Check for the product code ESPX5 on the cannula box. The affected lots are 268748 (expires 04/27/2020) and 269360 (expires 07/30/2020).
- Brand
Cooper Surgical- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot numbers 268748 or 269360 on the cannula box.
Contact Cooper Surgical
Reach out to Cooper Surgical for replacement or instructions on handling affected units.
Where it went and when
Where it was distributed
Distributed in 42 states and D.C..
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall states potential for unsealed pouches, but no specific injury mechanism is described. The risk is considered low.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0798-2020 (December 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0798-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.