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Centurion 310CRRecalls & 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
4
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00653160197471), received between Jan 27, 2020 and Sep 29, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 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: 1 reportsOct 2026: 0 reports2024202520261
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

  • Defective Component2
  • Damaged Thread1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Injury2
  • No Code Available1
  • Skin Tears1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Damaged Thread

    Patient problems: Skin Tears

    MAUDE report 50938589 ↗
  • MalfunctionMar 17, 2020Defective Component; Defective Component

    CIRCLAMP REMOVED FORESKIN WITHOUT THE USE OF SCALPEL.

    Patient problems: Injury

    MAUDE report 9842270 ↗
  • MalfunctionFeb 11, 2020Improper or Incorrect Procedure or Method

    DURING CIRCUMCISION: NO HEMOSTASIS, NO CLOSING - CLAMP REMOVED THE FORESKIN. CENTURION WAS USED TO CIRCUMCISE INFANT BY DOCTOR WHEN SHE CLOSED THE CLAMP, INSTEAD OF JUST PROVIDING HEMOSTASIS, IT REMOVED THE FORESKIN FROM THE PENIS.

    Patient problems: No Code Available

    MAUDE report 9693510 ↗
  • InjuryJan 27, 2020Defective Component; Defective Component

    CIRCLAMP REMOVED FORESKIN WITHOUT THE USE OF SCALPEL, REQUIRED SUTURES TO STOP BLEEDING.

    Patient problems: Injury

    MAUDE report 9633164 ↗

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-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-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-0837-05 · Apr 12, 2005 · Terminated
    Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.
  • Z-0836-05 · Apr 12, 2005 · Terminated
    Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.

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.