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FDA Medical Device Recalls (openFDA)

Deroyal Industries, Inc. Lafollette: DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp

Recall number
Z-3253-2011
Recalling firm
Deroyal Industries, Inc. Lafollette
Product
DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp
Status
Terminated
Initiated
2011-05-05
Posted
2011-09-16
Terminated
2013-01-30
Reason
The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.
Root cause
Other
Action
DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.
Quantity
100 units
Distribution
USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.
Lot, serial or model codes
Lot Number 21989639
510(k) numbers
not on file
PMA numbers
not on file
Product code
HFX
Firm FEI
3005011024
Firm city
La Follette
Firm state
TN
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

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