Z-0947-2017Class II

Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no...

Name: Z-0947-2017 Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no...
Creator: Aesculap Implant Systems LLC
Published: 2016-10-28
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2016-10-28 / Terminated

FDA source

Aesculap Implant Systems LLC began a recall of 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... on 2016-10-28. FDA classified it as Class II and gives the reason as "Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0947-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-28
Posted: 2017-01-05
Terminated: 2018-01-30
Recalling firm: Aesculap Inc
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
Product code: HFX Clamp, Circumcision
Reason for recall: Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
FDA root cause: Under Investigation by firm
Action: Aesculap sent an Urgent Medical Device Recall Notification letter dated October 28, 2016, to all affected customers were sent an Urgent Medical Device Recall Notification letter via Fed-Ex overnight.. Customers were asked to immediately remove the affect product from their inventory and return to Aesculap. A return label was provided to efficiently remove and return the affected products. Customers with questions should call 610-984-9414. For questions regarding this recall call 800-258-1946.
Quantity in commerce: 437 units
Distribution: Nationwide Distribution
Product codes and lots: Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0947-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0947-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-05

Product code HFX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)