The Recall Desk
HighFDA (Devices)·Z-1134-2014·Announced 2014-03-12

DeRoyal Circumcision Clamps Recalled for Manufacturing Defects

DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that could compromise surgical safety, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling three lots of DeRoyal ST. Circumcision Clamps (REF 32-1622, Size 1.3 cm). The recall involves 2,504 units distributed to healthcare facilities in New Jersey, Alabama, Texas, Washington, Illinois, Oklahoma, Virginia, Florida, Oregon, and Kansas.

The clamps were manufactured out of specification, which means they may not properly clamp at the surgical site completely. The affected lot numbers are 33347799, 33444071, and 33423747. The products are sterile, ethylene oxide (EO) sterilized, and require a prescription.

Healthcare providers should stop using the affected clamps and contact DeRoyal Industries for further instructions. Consumers should not use these products if they have them in their possession.

The recalled product

Product
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Affected units
2,504

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • lot numbers 33347799
  • 33444071
  • and 33423747

Distribution

Distributed in 10 states: