Centurion Medical Products Recalls Pelvic Exam Trays Due to Incomplete Seals
Centurion Medical Products Corporation is recalling various pelvic exam trays because incomplete seals on the sterile packages may compromise sterility.
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 involves a risk-of-harm product (sterile medical device) where the defect may compromise sterility, but no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling multiple models of pelvic exam trays, including the PE120, PE2200, PE2400, PE2515, PE2610, PE2700, PE2820, PE2835, PE2905, PE2955, PE2965, PE3125, PE3195, PE3285, PE3360, PE3375, PE3400, PE3475, PE3585, and PE860. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the devices.
The affected products were distributed nationwide and in Ghana. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the defect.
Healthcare facilities and consumers should stop using the affected trays and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
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
- HighDeRoyal Pelvic Exam Trays Recalled Due to Compromised Package Seals
FDA (Devices) · 2023-07-12
- HighCenturion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Ear Speculum Sets Recalled for Weak Seal and Sterility Risk
FDA (Devices) · 2024-04-10
- HighSurgical Tracheostomy Kit Recalled Due to Perforated Outer Wrapping Compromising Sterility
FDA (Devices) · 2023-02-22
- HighCenturion Recalls Sterile Graves Vaginal Speculums Due to Packaging Compromise
FDA (Devices) · 2019-08-14
- ModerateCenturion Medical Products Recalls Circumcision Trays Due to Iodine Levels
FDA (Devices) · 2018-03-28