CLASS II Device recall · Reported 18 Dec 2013 · FDA Enforcement Report

Axillent Debakey Grasping Forceps recalled

Karl Storz Endoscopy America is recalling Axillent Debakey Grasping Forceps, distributed nationwide in the US. The recall was initiated on 6 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code YX

Quantity recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0465-2014
FDA event ID: 66823
Recalling firm: Karl Storz Endoscopy America, Southbridge, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2013
FDA classified: 6 Dec 2013
Reported: 18 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

6 Nov 2013	Recall initiated by company
6 Dec 2013	Classified by FDA	+30 days
18 Dec 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution including states of: TX, PA, and NY.

Nationwide New York Pennsylvania Texas

Questions about this recall

Why was it recalled?

KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.

Which lots are affected?

Lot Code YX

Where was it sold?

Nationwide Distribution including states of: TX, PA, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Karl Storz Endoscopy America

All 17

Reported	Class	Recall	Company	Reason	Where
25 Dec 2013Device	CLASS II	Intubation Flexible Fiberscope recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Foreign Material	Nationwide
25 Dec 2013Device	CLASS II	Broncho Flexible Fiberscope recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Foreign Material	Nationwide
24 Jul 2013Device	CLASS II	27023WU Balloon Catheter., 2/pkg, sterile, contains latex recalled	Karl Storz Endoscopy America	Sterility	5 states
22 May 2013Device	CLASS II	Electrode, Barrel Bar (27050NX/6) recalled	Karl Storz Endoscopy America	Sterility	Nationwide
22 May 2013Device	CLASS II	Loop, Cutting/6) recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Sterility	Nationwide

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