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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- Centurion Medical Products Corporation
- 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 →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCenturion Ear Speculum Sets Recalled for Weak Seal and Sterility Risk
FDA (Devices) · 2024-04-10
- HighCenturion Recalls Sterile Graves Vaginal Speculums Due to Packaging Compromise
FDA (Devices) · 2019-08-14
- HighCenturion Universal Line Full Body Drape Kit Recalled for Packaging Defect
FDA (Devices) · 2019-11-13
- HighLaryngeal Mirror Weak Seal May Breach Sterility
FDA (Devices) · 2024-04-10
- HighCenturion Clamp kits recalled due to potential sterility breach risk
FDA (Devices) · 2024-04-10
- HighCenturion Scalpel Handles Recalled Due to Weak Seal Risk
FDA (Devices) · 2024-04-10