FDA (Devices) recall action 86009

Karl Storz Endoscopy recalled 8 products on 2020-09-02

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products: 8
Announced: 2020-09-02
Critical: 0
Units: 8,009

Why these products were recalled

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

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.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2020-09-02
Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates
Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.
Product
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz is recalling 380 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid infection.
Product
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions
Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.
Product
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions
Karl Storz is recalling 463 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.
Product
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz Endoscopy is recalling 2,668 flexible intubation video endoscopes to provide updated sterilization instructions and prevent incomplete sterilization.
Product
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible Intubation Fiberscope Recall for Sterilization Instructions
Karl Storz is recalling 650 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid patient infection.
Product
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Update
Karl Storz Endoscopy is recalling 91 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of ethylene oxide on specific devices to avoid incomplete sterilization and potential patient infection.
Product
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states
HighFDA (Devices)··2020-09-02
Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz is recalling 2,083 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.
Product
Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Distribution
51 states