Z-1320-2016Class II

Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during...

Name: Z-1320-2016 Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during...
Creator: Cardinal Health
Published: 2016-02-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-02-29 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant on 2016-02-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1320-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-29
Posted: 2016-04-05
Terminated: 2018-03-02
Recalling firm: Medtronic, Inc.
Product: Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Product code: OHG Circumcision Tray
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Cardinal Health sent an URGENT: PRODUCT RECALL letter dated February 29, 2016, to affected consignees explaining the reason for the product recall and actions that should be taken by the end user. These included the following actions: 1. STOP using affected product. 2. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices. 3. NOTIFY any customers to whom you may have distributed product affected by this recall. 4. CONTACT the appropriate Customer Service group to arrange for return of any affected product you may have: " Hospital800.964.5227 " Distributor800.635.6021 The firm asks that consignees who have question or requests of special assistance relating to the recall should contact Cardinal Health Customer Advocacy at 800.292.9332. For questions regarding this recall call 847-473-1500.
Quantity in commerce: SSI-0034: 380 units and 10-1100: 60 units
Distribution: Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Product codes and lots: SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1320-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1320-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code OHG

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)