Recall record at a glance
| Official record | Z-2135-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | CooperSurgical, Inc. |
| Report date | Jul 30, 2025 |
| Recall initiation date | Jun 11, 2025 |
| Quantity | 171 units |
| Location | Trumbull, CT, United States |
Official product description
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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