Centurion Circumcision Trays Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products is recalling 1,986 circumcision trays 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 (compromised sterility of a surgical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 1,986 units of various Centurion Circumcision Trays. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the devices.
The affected products were distributed nationwide and to Ghana. The source text does not specify the number of reported illnesses or injuries associated with this recall.
Healthcare facilities and consumers should stop using the affected trays and contact Centurion Medical Products Corporation for further instructions on returns or replacements.
The recalled product
- Product
- Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 1,986
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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