Z-1134-2014Class II

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by...

Name: Z-1134-2014 DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by...
Creator: DeRoyal Industries Inc
Published: 2014-01-16
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2014-01-16 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries on 2014-01-16. FDA classified it as Class II and gives the reason as "Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1134-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-16
Posted: 2014-03-04
Terminated: 2015-10-13
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Product code: HFX Clamp, Circumcision
Reason for recall: Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal initiated the recall by sending overnight letters to its direct accounts on 01/16/2014. If distributors inform DeRoyal of further distribution, DeRoyal will contact those consignees in the same manner. If necessary, further communications will be sent in the form of another mailing, phone calls, and emails to materials management personnel when possible.
Quantity in commerce: 2504 units
Distribution: US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
Product codes and lots: lot numbers 33347799, 33444071, and 33423747

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1134-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1134-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

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)