HSG Tray 6050TRecalls & reported problems
Coopersurgical, Inc. · For hysterosalpingography procedures · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K920803); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 11, 2025Open, Classified
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.
Z-2135-2025 · Root cause: Under Investigation by firm · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K920803. One submission often covers many models, so check the product and lot details in each record.
- Z-2137-2025 · Jun 11, 2025 · Open, ClassifiedEndosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Z-2136-2025 · Jun 11, 2025 · Open, ClassifiedEndosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Other Speculum, Vaginal, Nonmetal devices
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal4 reports
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal3 reports
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal2 reports
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal1 report
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal1 report
- MEDLINE DYND70401SMedline Industries, Inc. · Speculum, vaginal, nonmetal1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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