CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report
Gomco Style Circumcision Clamp Trays is an instrument used recalled
Cardinal Health is recalling Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of, distributed nationwide in the US. The recall was initiated on 29 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1320-2016
- FDA event ID
- 73497
- Recalling firm
- Cardinal Health, Mc Gaw Park, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Feb 2016
- FDA classified
- 5 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Feb 2016 | Recall initiated by company | |
| 5 Apr 2016 | Classified by FDA | +36 days |
| 13 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
Product as listed by the FDA
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Where it was distributed
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Nationwide AlabamaArkansasKansasMississippiNorth CarolinaTexasVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
Which lots are affected?
SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406
Where was it sold?
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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