CooperSurgical recalls HSG Procedure Tray model 6050T with non-sterile iodine pouches incorrectly labeled as sterile. This could lead to infection risks during hysterosalpingography procedures.
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.
CooperSurgical is recalling HSG Procedure Trays model 6050T because the iodine pouches inside are non-sterile but labeled as sterile. Using these pouches during medical procedures could increase infection risks.
The iodine pouches in the HSG Procedure Tray are non-sterile but labeled as sterile. This mislabeling could lead to infection if the pouches are used during medical procedures without proper sterilization.
Healthcare providers using the HSG Procedure Tray model 6050T for hysterosalpingography procedures are affected. Patients undergoing these procedures may be at risk if the iodine pouches are used without proper sterilization.
Check for model number 6050T on the HSG Procedure Tray. Lot numbers 339331, 339327, 339333, 339334, and 343007 are affected. The product is used in hysterosalpingography procedures.
Verify if the iodine pouches are labeled as sterile; if not, stop using the tray immediately.
The HSG Procedure Trays contain non-sterile iodine pouches that are incorrectly labeled as sterile.
The HSG Procedure Tray is used in hysterosalpingography and sonohysterography procedures.
Look for model number 6050T and lot numbers 339331, 339327, 339333, 339334, or 343007.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2135-2025 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-2135-2025 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
