FDA Medical Device Recalls (openFDA)
Cardinal Health: Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
- Recall number
- Z-1320-2016
- Recalling firm
- Cardinal Health
- Product
- Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
- Status
- Terminated
- Initiated
- 2016-02-29
- Posted
- not on file
- Terminated
- 2018-03-02
- Reason
- 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
- 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
- SSI-0034: 380 units and 10-1100: 60 units
- Distribution
- Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
- Lot, serial or model codes
- SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHG
- Firm FEI
- 3001236905
- Firm city
- Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28