Karl Storz Endoscopy America Inc

How does FDA spell Karl Storz Endoscopy America Inc?

FDA publishes this company under 9 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Showing 8 of 9.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Karl Storz Endoscopy America Inc file in?

82 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 82.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Karl Storz Endoscopy America Inc had a recall?

openFDA lists 19 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

• Z-0526-2014Class IITerminatedCAL13 November 2013

  KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.

• Z-0527-2014Class IITerminatedECQ13 November 2013

  KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.

• Z-0465-2014Class IITerminatedGCJ6 November 2013

  KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.

• Z-1728-2013Class IITerminatedGBA31 May 2013

  Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.

• Z-1216-2013Class IITerminatedOAY16 August 2012

  The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.

Showing the 5 most recently initiated of 19.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Karl Storz Endoscopy America Inc cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is Karl Storz Endoscopy America Inc registered?

FDA lists 2 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.