FDA Device Intelligence
HomeDevice types › HFX

Clamp, Circumcision

FDA product code HFX · Class 2 · Obstetrics/Gynecology

130
Registered devices
862
Adverse events
14
Recalls
27
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-09-03MEDLINE INDUSTRIES, LP - NorthfieldProduct has been identified as having holes in the packaging.
2023-05-23MEDLINE INDUSTRIES, LP - NorthfieldThe kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
2023-03-02MEDLINE INDUSTRIES, LP - NorthfieldThe CirClamp subassembly found in the kit was the incorrect size.
2019-08-28Centurion Medical Products CorporationA 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.
2019-08-28Centurion Medical Products CorporationA 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.
2016-10-28Aesculap Implant Systems LLCAesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and theref
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and theref
2014-01-16DeRoyal Industries IncThree lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
2011-05-05Deroyal Industries, Inc. LafolletteThe firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.