Centurion Medical Products Recalls Surgical Trays Due to Incomplete Seals
Centurion Medical Products is recalling specific surgical 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 (compromised sterility) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of DYNTray surgical trays, including the Debridement Tray with Safety Scalpel and the Newborn Circumcision Tray. The recall is being conducted because incomplete seals on the sterile packages may compromise the sterility of the medical devices.
The affected products were distributed nationwide and in Ghana. The specific product codes involved are DYNJ08835 (Debridement Tray with Safety Scalpel) and DYNJ1000 (Newborn Circumcision Tray). The source text does not specify the exact number of units recalled or report any illnesses or injuries associated with this defect.
Healthcare facilities and consumers should stop using the affected trays and contact Centurion Medical Products Corporation for instructions on how to return the products or obtain a replacement.
The recalled product
- Product
- Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
- 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
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