Centurion Debridement Tray Recalled for Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling Debridement Trays because incomplete seals on the sterile package 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 medical device where compromised sterility poses a risk of harm (infection), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Debridement Trays (Item Number I86625). The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the product.
The affected product is distributed nationwide and in Ghana. The specific lot codes involved in this recall are 2019040590 and 2018111690.
Healthcare facilities and consumers should stop using the affected Debridement Trays and contact Centurion Medical Products Corporation for further instructions or a return.
The recalled product
- Product
- Centurion- I86625 DEBRIDEMENT TRAY
- Manufacturer
- Centurion Medical Products Corporation
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 (2)
- Lot Code: 2019040590
- 2018111690
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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