Z-0527-2014Class II

Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment...

Name: Z-0527-2014 Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment...
Creator: Karl Storz Endoscopy America Inc
Published: 2013-11-13
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2013-11-13 / Terminated

FDA source

Karl Storz Endoscopy America Inc began a recall of Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for... on 2013-11-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0527-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-13
Posted: 2013-12-17
Terminated: 2014-03-27
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: 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 code: ECQ Aligner, Bracket, Orthodontic
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.
FDA root cause: Under Investigation by firm
Action: The firm, KARL STORZ, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated November 8, 2013 to all their customers on November 13, 2013. The letter describes the product, problem and actions to be taken.The letter informs the customers that the endoscopes incorporated a lumen material that is only approved for use as an external surface material and not included in the STERRAD NX and 100NX FDA-cleared claims for use in flexible endoscope lumens. The customers were instructed to follow the recommended processing methods included in the letter. Customers with questions about the letter are instructed to contact the undersigned and the Technical Services at (800) 421-0837, ext 5350.
Quantity in commerce: 141 units
Distribution: Nationwide Distribution.
Product codes and lots: C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0526-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17
Z-0527-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

Product code ECQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)