Centurion CIRCLAMP Recall Due to Angle Mismatch Defect
Centurion Medical Products is recalling 204 units of the CIRCLAMP W/1.3 CM BELL because a design mismatch may cause the clamp to remove foreskin without a scalpel.
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 with a defect that may cause unintended tissue removal during a surgical procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling 204 units of the Centurion CIRCLAMP W/1.3 CM BELL, a single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. The recall involves batch/lot 2019061201, which was distributed nationwide.
The recall was initiated due to a mismatch between the angle of the hole in the base and the angle of the bell. This defect may cause the clamp to remove foreskin without the use of a scalpel.
Healthcare providers and consumers who have this product should stop using it and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 204
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 (1)
- Batch/Lot: 2019061201
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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Same hazard · unintended tissue removal
See all →- HighCenturion Circlamp Recalled for Angle Mismatch Defect
FDA (Devices) · 2019-10-16
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