CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report

Broncho Flexible Fiberscope recalled by Karl Storz Endoscopy America

Karl Storz Endoscopy America is recalling Broncho Flexible Fiberscope, distributed nationwide in the US. The recall was initiated on 13 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesC1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E

Quantity recalled141 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-0527-2014
FDA event ID: 66862
Recalling firm: Karl Storz Endoscopy America, Southbridge, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Nov 2013
FDA classified: 17 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

13 Nov 2013	Recall initiated by company
17 Dec 2013	Classified by FDA	+34 days
25 Dec 2013	Published in enforcement report	+8 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 Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E

Where was it sold?

Nationwide Distribution.

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

Other products in this recall event

1 other product · FDA event 66862

Reported	Class	Recall	Company	Reason	Where
25 Dec 2013	CLASS II	Intubation Flexible Fiberscope recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Foreign Material	Nationwide

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
18 Dec 2013Device	CLASS II	Axillent Debakey Grasping Forceps recalled	Karl Storz Endoscopy America	Labeling Errors	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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