Aesculap Recalls Gomco Circumcision Clamps Due to Excessive Bleeding Reports
Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps nationwide after receiving complaints of excessive bleeding following use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device associated with a risk of harm (excessive bleeding) where specific injury counts or fatalities are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps with separate O-Ring Components. The devices are packaged non-sterile, have no shelf-life, and are intended for use in circumcision surgeries. The recall covers specific material codes: MG096R (1.1 CM), MG097R (1.3 CM), MG227 (1.45CM), MG228 (1.6CM), MG229 (2.1 CM), and MG230 (2.6CM).
The recall was initiated after Aesculap received complaints of excessive bleeding after the use of these clamps. The affected devices were distributed nationwide.
Healthcare providers and consumers should stop using the affected Gomco Circumcision Clamps immediately. Users should contact Aesculap Implant Systems LLC for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 437
Distribution
Distributed nationwide across the United States.
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