CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
Endosee System Convenience Kit recalled by CooperSurgical
CooperSurgical is recalling Endosee System Convenience Kit, distributed nationwide in the US. The recall was initiated on 11 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2136-2025
- FDA event ID
- 97028
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2025
- FDA classified
- 18 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 Jun 2025 | Recall initiated by company | |
| 18 Jul 2025 | Classified by FDA | +37 days |
| 30 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Which lots are affected?
Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97028This product is part of a recall event; the main page for the event is Endosee System Convenience Kit with IV Tube recalled by CooperSurgical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Endosee System Convenience Kit with IV Tube recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide | |
| CLASS II | HSG Procedure Tray recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
More recalls from CooperSurgical
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | HSG Procedure Tray recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | Endosee System Convenience Kit with IV Tube recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | K-Systems R65 Trolley recalled by CooperSurgical | CooperSurgical | Temperature Abuse | 14 states |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |