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Lower risk Medical device recall · FDA · Published June 11, 2025

CooperSurgical Endosee System Convenience Kit with IV Tube: Non-sterile Iodine Pouches

CooperSurgical recalls Endosee System Convenience Kit with IV Tube (model ES-TRAY-IV) due to non-sterile iodine pouches labeled as sterile. Affected units include specific lot numbers and model.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2137-2025Medical deviceCooperSurgical ›
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Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

CooperSurgical is recalling Endosee System Convenience Kits with IV Tubes because the iodine pouches are non-sterile but labeled as sterile. This could lead to infections if used in medical procedures without proper sterilization. Read more at govinfonow.com/recall/52071-coopersurgical-endosee-system-convenience-kit-with-iv-tube-non-sterile.

Source Summary by GovInfoNow · govinfonow.com/recall/52071-coopersurgical-endosee-system-convenience-kit-with-iv-tube-non-sterile · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2137-2025

Cite this page

“CooperSurgical Endosee System Convenience Kit with IV Tube: Non-sterile Iodine Pouches.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/52071-coopersurgical-endosee-system-convenience-kit-with-iv-tube-non-sterile. Based on FDA recall #Z-2137-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2025%22&limit=1).

CooperSurgical, Inc. voluntarily recalled the Endosee System Convenience Kit with IV Tube (Model ES-TRAY-IV) due to non-sterile iodine pouches mislabeled as sterile, according to the FDA on June 11, 2025.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: Endosee System Convenience Kit with IV Tube
  • Model Number: ES-TRAY-IV
  • UDI-DI: 60888937026674
  • Lot Numbers: 344355, 550009229, 550009230, 550009590, 550013213
  • Units affected: 475

The hazard

The recall involves HSG Procedure Trays and Endosee System Convenience Kits containing non-sterile iodine pouches. Peel away lid labels incorrectly identify these pouches as sterile, creating a risk of infection if used.

Context

GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since October 6, 2017. Recent brand recalls include the Neonatal CPAP Replacement Set (August 11, 2026) and the K-Systems G85 Mini Incubator (November 15, 2024). Other recent recalls of similar products include the Medline Centurion Circumcision Kit (March 16, 2026), the Vortex Surgical I2 Injection Kit (December 16, 2025), and the Intuitive Surgical Ion Vision Probe Bag (December 4, 2025).

How to tell if you have this one

Check for the model number ES-TRAY-IV on the kit. Affected units include lot numbers 344355, 550009229, 550009230, 550009590, and 550013213.

  • Brand
    CooperSurgical
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.
Recall numberProduct, codes & lotsQuantity
Z-2135-2025HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.; Model Number: 6050T. UDI-DI 60888937003262. Lot Numbers: 339331, 339327, 339333, 339334, 343007.171 units
Z-2136-2025Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit; Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.991 units
Z-2137-2025Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.; Model Number: ES-TRAY-IV. UDI-DI: 60888937026674. Lot Numbers: 344355, 550009229, 550009230, 550009590, 550013213.475 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Model

    Look for the model number ES-TRAY-IV on the Endosee System Convenience Kit with IV Tube.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 46 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jun 11, 202512. FDA classified it Class II: Jul 18, 202523. Published in FDA’s Enforcement Report: Jul 30, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this kit?

The recall does not require stopping use immediately; however, users should check the model and lot numbers to ensure they have an affected unit.

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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-2137-2025 (June 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2137-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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.