Z-0121-2020Class II

Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis...

Name: Z-0121-2020 Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis...
Creator: Centurion Medical Products Corporation
Published: 2019-08-28
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-08-28 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of 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... on 2019-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0121-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-28
Posted: 2019-10-10
Terminated: 2020-07-23
Recalling firm: Centurion Medical Products, LP
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
Product code: HFX Clamp, Circumcision
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Centurion Medical Products issued Notification via Certified Mail, Return Receipt on 8/28/19 to customers who received affected product. Letter states reason for recall, helath risk and action to take: identify inventory within your possession and cease use immediately. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of your response Centurion Representative will contact you regarding retrieval of the product from your facility, if required. Forward this recall information to any facilities to whom this product may have been further distributed, instructing them to cease use immediately. Questions: Kara A. Kowalczy Director of Quality Assurance(517) 546-5400 Ext.1122. Centurion mailed four (4) additional customer letters on 9/27 /2019 via Certified Mail, Return Receipt.
Quantity in commerce: 204 each
Distribution: Nationwide
Product codes and lots: Batch/Lot: 2019061201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-10
Z-0121-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-10

Product code HFX

K890897Class IICenturion CirclampTri-State Hospital Supply Corp. / cleared 1989-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)