Karl Storz Endoscopy America Inc: Medical Device Recall in 2013 - (Recall #: Z-0527-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 13, 2013

Date Posted: December 25, 2013

Recall Number: Z-0527-2014

Event ID: 66862

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.

Status: Terminated

Product Quantity: 141 units

Code Information:

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

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated