Manufacturer

Karl Storz Endoscopy America Inc

17 recalls in our database name Karl Storz Endoscopy America Inc as the manufacturing or recalling firm.

What the numbers show

Total: 17
Critical: 0
Severe: 0
Most recent: 2013-12-25

Of the 17 recalls from Karl Storz Endoscopy America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

ModerateFDA (Devices)·Z-0526-2014·2013-12-25
Karl Storz Recalls Flexible Intubation Fiberscopes Due to Material Issue
Karl Storz Endoscopy America is recalling specific flexible intubation fiberscopes because the suction channel material is incompatible with STERRAD sterilization systems.
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 visua
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0527-2014·2013-12-25
Karl Storz Recalls Flexible Broncho Fiberscopes Due to Material Issue
Karl Storz Endoscopy America is recalling 141 flexible broncho fiberscopes because the suction channel material is not listed for STERRAD sterilization systems.
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 " Unc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0465-2014·2013-12-18
Karl Storz Recalls Misidentified Axillent Debakey Grasping Forceps
Karl Storz is recalling 7 units of Axillent Debakey Grasping Forceps because they were mislabeled as a different model.
Product
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1728-2013·2013-07-24
Karl Storz Balloon Catheter Recalled for Potential Sterility Compromise
Karl Storz Endoscopy America is recalling 27023WU Balloon Catheters because packaging defects may compromise sterility. The recall affects 40 units distributed to five US states.
Product
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1311-2013·2013-05-22
Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage
Karl Storz is recalling 9,432 units of sterile electrode accessories because damaged packaging may allow airborne contamination.
Product
Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1316-2013·2013-05-22
Karl Storz Cutting Loops Recalled for Potential Sterile Packaging Damage
Karl Storz is recalling specific cutting loops due to possible damage to sterile packaging, which may result in airborne contamination.
Product
Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1307-2013·2013-05-22
Karl Storz Recalls Pointed Coagulation Electrodes Due to Packaging Damage
Karl Storz is recalling 9,432 units of pointed coagulation electrodes because damage to the sterile blister tray packaging may allow airborne contamination.
Product
Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1305-2013·2013-05-22
Karl Storz Cutting Electrode Recall Due to Packaging Damage
Karl Storz is recalling cutting electrodes because damaged sterile packaging may allow airborne contamination.
Product
Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1315-2013·2013-05-22
Karl Storz Cutting Electrodes Recalled for Packaging Damage
Karl Storz is recalling 9,432 cutting electrodes due to possible damage to sterile packaging that may allow airborne contamination.
Product
Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1308-2013·2013-05-22
Karl Storz Recalls Sterile Electrodes Due to Packaging Damage
Karl Storz is recalling 9,432 sterile ball-end electrodes because damaged packaging may allow airborne contamination.
Product
Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1310-2013·2013-05-22
Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage
Karl Storz is recalling 9,432 sterile electrode accessories because damaged packaging may allow airborne contamination.
Product
Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1306-2013·2013-05-22
Karl Storz Cutting Electrode Recall Due to Packaging Damage
Karl Storz is recalling 9,432 cutting electrodes due to possible sterile packaging damage that may allow airborne contamination.
Product
Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1312-2013·2013-05-22
Karl Storz VaporCut Electrode Recalled for Packaging Damage
Karl Storz is recalling 9,432 VaporCut electrodes due to possible sterile packaging damage that may allow airborne contamination.
Product
Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1313-2013·2013-05-22
Karl Storz Cutting Loops Recalled for Packaging Damage
Karl Storz is recalling 9,432 cutting loops due to possible sterile packaging damage that may allow airborne contamination.
Product
Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1314-2013·2013-05-22
Karl Storz Recalls Cold Straight Knives Due to Packaging Damage
Karl Storz is recalling 9,432 units of cold straight knives because damaged sterile packaging may allow airborne contamination.
Product
Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1309-2013·2013-05-22
Karl Storz Recalls Roller Ball Electrodes Due to Packaging Damage
Karl Storz is recalling 9,432 Roller Ball Electrodes because damaged sterile packaging may allow airborne contamination.
Product
Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1216-2013·2013-05-15
Karl Storz Recalls Photodynamic Diagnosis Instruction Manuals for Safety Updates
Karl Storz is recalling 15 units of PDD D-Light C System instruction manuals because they contain important safety-related changes.
Product
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Category
Medical Device
Distribution
Distributed nationwide