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PremierPro Vaginal Speculum
PRESTIGE AMERITECH, LTD. · Model 5313 · UDI-DI 00811220032142
HIB
Prescription
10
510(k) clearances
152
Adverse events
6
Recalls
116
Facilities
Description
PremierPro Vaginal Speculum Disposal Methods: Disposal practices must be in compliance with all Federal, State and Local laws and regulations. DO NOT DUMP INTO ANY SEWERS, ON THE GROUND OR INTO ANY BODY OF WATER.
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.