FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy America Inc: 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.
- Recall number
- Z-0526-2014
- Recalling firm
- Karl Storz Endoscopy America Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-11-13
- Posted
- 2013-12-17
- Terminated
- 2014-03-27
- Reason
- 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.
- 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
- 1516 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAL
- Firm FEI
- 2020550
- Firm city
- Southbridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28