Karl Storz Endoscopy: Medical Device Recall in 2020 - (Recall #: Z-1530-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

Product Classification:

Class II

Date Initiated: August 27, 2019

Date Posted: April 1, 2020

Recall Number: Z-1530-2020

Event ID: 84896

Reason for Recall:

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

Status: Ongoing

Product Quantity: 73 scopes

Code Information:

All Lots

Distribution Pattern:

US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda

Voluntary or Mandated:

Voluntary: Firm initiated