openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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
device · product 3 of 3
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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
