FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy America Inc: Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
- Recall number
- Z-0465-2014
- Recalling firm
- Karl Storz Endoscopy America Inc
- Product
- Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
- Status
- Terminated
- Initiated
- 2013-11-06
- Posted
- 2013-12-06
- Terminated
- 2014-01-13
- Reason
- KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
- Root cause
- Labeling mix-ups
- Action
- Karl Storz Endosocopy sent a Safety Alert letter dated November 6, 2013, to all customers who received the 33821DYD Axillent Debakey Grasping Forceps. The letter informed the customers of the problems identified and the actions to be taken. Customers were asked to set aside the mislabeled product and return the mislabeled instruments with the RMA (Return Material Authorization) number issued to them. Customers were instructed to fax or email completed recall response form to (424) 218-8519. Customers with any questions were instructed to call (800) 421-0837 ext 8289. For questions regarding this recall call 746-708-8440.
- Quantity
- 7 units
- Distribution
- Nationwide Distribution including states of: TX, PA, and NY.
- Lot, serial or model codes
- Lot Code YX
- 510(k) numbers
- ["K934937"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2020550
- Firm city
- Southbridge
- Firm state
- MA
- 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