Food, drugs, devices › Karl Storz Endoscopy America Inc
Device recall: Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
FDA enforcement event 55358 is a device recall by Karl Storz Endoscopy America Inc of El Segundo, CA, initiated 1 Jun 2009 and classified Class II, with 12 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 26 device enforcement events initiated in 2009 carry the same class.
Status: Terminated, terminated 13 May 2013. Initiation: voluntary: firm initiated. Karl Storz Endoscopy America Inc has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Karl Storz Endoscopy America Inc, El Segundo, CA.
Reason for recall
"Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination."
Distribution
"Distributed Nationwide and in Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1305-2013 | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1306-2013 | Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1307-2013 | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1308-2013 | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1309-2013 | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1310-2013 | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1311-2013 | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1312-2013 | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1313-2013 | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1314-2013 | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1315-2013 | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
| Z-1316-2013 | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | 9432 units | Class II | Terminated | 22 May 2013 |
Context
Other enforcement events for Karl Storz Endoscopy America Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Nov 2013 | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1 | Device | Class II | 2 |
| 6 Nov 2013 | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissu | Device | Class II | 1 |
| 31 May 2013 | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for th | Device | Class II | 1 |
| 16 Aug 2012 | KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Cam | Device | Class II | 1 |
All 5 events for Karl Storz Endoscopy America Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed Nationwide and in Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 May 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.