RegWardenFDA facility compliance records
Recall

Class II — DeRoyal Industries Inc

Recalling firmDEROYAL INDUSTRIES, INC.
Registered facilityView this company's 13 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThree lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
ProductDeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Quantity2504 units
DistributionUS Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
Initiated2014-01-16
Classified2014-03-04
Terminated2015-10-13
Recall numberZ-1134-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — DeRoyal Industries Inc (Z-1134-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67442/

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