CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
Centurion Circlamp W/ Bell-single-use recalled
Centurion Medical Products is recalling Centurion Circlamp W/ Bell-single-use, disposable instrument used to compress the, distributed nationwide in the US. The recall was initiated on 28 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0121-2020
- FDA event ID
- 83774
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2019
- FDA classified
- 10 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Aug 2019 | Recall initiated by company | |
| 10 Oct 2019 | Classified by FDA | +43 days |
| 16 Oct 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Centurion Circlamp W/ Bell-single-use, disposable instrument used to compress the recalled?
Yes. Centurion Medical Products recalled Centurion Circlamp W/ Bell-single-use, disposable instrument used to compress the on 28 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0121-2020.
Why was it recalled?
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
Which lots are affected?
Batch/Lot: 2019061201
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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