FDA (Devices) recall action 95975
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.
Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.