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Ultraspec
ROBINSON HEALTHCARE LIMITED · Model 9157 · UDI-DI 05010058091573
HIB
Prescription
10
510(k) clearances
152
Adverse events
6
Recalls
116
Facilities
Description
EcoGold Speculum Broad Sterile X25
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | OBP Medical Corporation | There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the hea |
| 2025-06-11 | CooperSurgical, Inc. | 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. |
| 2025-06-11 | CooperSurgical, Inc. | 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. |
| 2025-06-11 | CooperSurgical, Inc. | 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. |
| 2015-10-02 | Welch Allyn Inc | The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low v |
| 2015-04-13 | CooperSurgical, Inc. | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.