Z-0465-2014Class II

Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to...

Name: Z-0465-2014 Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to...
Creator: Karl Storz Endoscopy America Inc
Published: 2013-11-06
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2013-11-06 / Terminated / root cause: labeling and UDI

FDA source

Karl Storz Endoscopy America Inc began a recall of Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue on 2013-11-06. FDA classified it as Class II and gives the reason as "KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0465-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Posted: 2013-12-06
Terminated: 2014-01-13
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
Root cause tag: labeling and UDI
FDA 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 in commerce: 7 units
Distribution: Nationwide Distribution including states of: TX, PA, and NY.
Product codes and lots: Lot Code YX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0465-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0465-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06

Product code GCJ

K934937Class IIKarl Storz Biop/bask Cut/grasp Dissec/flex/cut ForcKARL STORZ Endoscopy-America, Inc. / cleared 1994-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)