Karl Storz Endoscopy America Inc: Medical Device Recall in 2013 - (Recall #: Z-0526-2014)

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:

Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visual access to the larynx and tracheobronchial tree.

Product Classification:

Class II

Date Initiated: November 13, 2013

Date Posted: December 25, 2013

Recall Number: Z-0526-2014

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: 1516 units

Code Information:

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

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated