FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
- Recall number
- Z-1134-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-01-16
- Posted
- 2014-03-04
- Terminated
- 2015-10-13
- Reason
- 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
- 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
- 2504 units
- Distribution
- US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
- Lot, serial or model codes
- lot numbers 33347799, 33444071, and 33423747
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HFX
- Firm FEI
- 1043214
- Firm city
- Powell
- 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