The Recall Desk
HighFDA (Devices)·Z-1072-2020·Announced 2020-02-12

Centurion Vaginal Speculums Recalled Due to Incomplete Sterile Package Seals

Centurion Medical Products is recalling sterile vaginal speculums because incomplete seals may compromise sterility. The recall covers 1,100 units distributed nationwide and in Ghana.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.

Plain-English summary

Centurion Medical Products Corporation is recalling 1,100 units of Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the device.

The affected product was distributed nationwide and in Ghana. The specific code for the recalled items is VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT 2019021290.

Healthcare providers and consumers should stop using the affected speculums and contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Affected units
1,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT 2019021290

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 54 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 54 products in this recall →