Karl Storz Endoscopy America Inc

Complete recall history across all FDA and CPSC categories — 17 total recalls

Karl Storz Endoscopy America Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by Karl Storz Endoscopy America Inc

Date Product Reason Class
Nov 13, 2013 Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fibersco... Class II
Nov 13, 2013 Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fibersco... Class II
Nov 6, 2013 Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 338... Class II
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon ... Class II
Aug 16, 2012 KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manual... The recall was initiated because Karl Storz has confirmed that the Photodynam... Class II
Jun 1, 2009 Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II
Jun 1, 2009 Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... Possible damage to the sterile packaging (blister tray) of some Karl Storz st... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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