Centurion Dental Kits Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling 1,720 dental kits because incomplete seals on the sterile packaging 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 hazard (compromised sterility) is present, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 1,720 units of Centurion Dental Kits, specifically the DH775 Premium Dental Exam Tray and DYKA1169B Dental Kit. The recall is due to incomplete seals on the sterile packaging, which may compromise the sterility of the products.
The affected products were distributed nationwide and in Ghana. The specific lot codes involved are 2019041790, 2019012890, and 2019011690.
Consumers and healthcare providers should stop using these products and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Dental Kits
- Hazard
- Affected units
- 1,720
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)
- DH775 PREMIUM DENTAL EXAM TRAY- 2019041790
- 2019012890 DYKA1169B DENTAL KIT 2019011690
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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