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Centurion 330CRKRecalls & reported problems

Centurion Medical Products Corporation · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
1

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10653160309901), received between Mar 26, 2020 and Jul 8, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K890897); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 4 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Sep 3, 2024Open, Classified

    Product has been identified as having holes in the packaging.

    Z-0133-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available5
  • Insufficient Device Problem Information2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding6
  • Abrasion1
  • Genital Bleeding1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    INCREASED BLEEDING.

    Patient problems: Genital Bleeding

    MAUDE report 19690456 ↗
  • InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    ACCORDING TO THE CUSTOMER ON 3/11, "A CIRCUMCISION WAS COMPLETED USING CIRCLAMP. BRIGHT, RED BLEEDING WAS NOTED TWICE AND REQUIRED SURGICEL APPLICATION FOR INTERVENTION APPROXIMATELY 17 HOURS AFTER PROCEDURE COMPLETED."

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 19291176 ↗
  • InjuryApr 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE CUSTOMER ON 3/15/2024, "CIRCLAMP WAS USED FOR MALE CIRCUMCISION AND SURGICEL WAS APPLIED TO STOP EXCESSIVE BLEEDING. SURGERY WAS NOT REQUIRED".

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 19124649 ↗
  • InjuryMar 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY ON (B)(6) 2024 THERE WAS INCREASED BLEEDING NOTED POST PROCEDURE REQUIRING THE FACILITY TO USE "SURCIGEL TO CONTROL BLEEDING".

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 18826229 ↗
  • InjuryMar 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY ON (B)(6) 2024 THERE WAS INCREASED BLEEDING NOTED POST PROCEDURE REQUIRING THE FACILITY TO USE "SURCIGEL TO CONTROL BLEEDING".

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 18826022 ↗
  • InjuryMar 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY ON (B)(6) 2024 THERE WAS INCREASED BLEEDING NOTED POST PROCEDURE REQUIRING THE FACILITY TO USE "SURCIGEL TO CONTROL BLEEDING".

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 18825867 ↗
  • InjuryMar 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY ON (B)(6) 2024 THERE WAS INCREASED BLEEDING NOTED POST PROCEDURE REQUIRING THE FACILITY TO USE "SURCIGEL TO CONTROL BLEEDING".

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 18825742 ↗
  • InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ABRASION OF THE SKIN RESULTING IN BLEEDING THAT REQUIRED SUTURES.

    Patient problems: Abrasion

    MAUDE report 9886256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K890897. One submission often covers many models, so check the product and lot details in each record.

  • Z-2649-2023 · May 23, 2023 · Open, Classified
    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
  • Z-1407-2023 · Mar 2, 2023 · Open, Classified
    Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
  • Z-0121-2020 · Aug 28, 2019 · Terminated
    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
  • Z-0120-2020 · Aug 28, 2019 · Terminated
    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
  • Z-0836-05 · Apr 12, 2005 · Terminated
    Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.
  • Z-0837-05 · Apr 12, 2005 · Terminated
    Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.

Other CLAMP, CIRCUMCISION devices

All CLAMP, CIRCUMCISION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.