Centurion Medical Recalls Sterile Surgical Trays Due to Incomplete Seals
Centurion Medical Products Corporation is recalling specific sterile surgical trays because incomplete seals may compromise sterility. The affected products were 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 involves a risk-of-harm product (sterile surgical instruments) where the hazard is compromised sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific sterile surgical trays, including the Circumcision Tray Sterile, Debridement Tray with Safety Scalpel, and Newborn Circumcision Tray. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the instruments.
The affected products include lot numbers 2019010790 (Circumcision Tray Sterile), 2018111390 (Debridement Tray with Safety Scalpel), and 2019021890 (Newborn Circumcision Tray). These products were distributed nationwide and in Ghana.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the affected trays. They should contact Centurion Medical Products Corporation for instructions on returning or disposing of the products.
The recalled product
- Product
- Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
- Manufacturer
- Centurion Medical Products Corporation
- 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
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