Centurion Circlamp Recalled for Angle Mismatch Defect
Centurion Medical Products is recalling 1,530 Circlamps due to a design mismatch that may cause the device to remove foreskin without a scalpel.
What this means for you
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 defect that poses a risk of unintended tissue removal (injury) during a surgical procedure, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling 1,530 units of the Centurion CIRCLAMP W/1.1CM BELL. This single-use, disposable instrument is used to compress the foreskin of the penis during circumcision of a male infant. The affected units are from batch/lot 2019061801 and were distributed nationwide.
The recall is 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.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 1,530
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: 2019061801
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 Recall Due to Angle Mismatch Defect
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