Hazard

Incomplete Sterilization recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 8
Critical: 0
Severe: 0
Most recent: 2023-08-09

Of the 8 incomplete sterilization recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all incomplete sterilization recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

HighFDA (Devices)·Z-2286-2023·2023-08-09
Scican STATCLAVE G4 Chamber Autoclave Recall for Sterilization Risk
Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.
Product
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2023·2023-08-09
STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk
FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.
Product
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2894-2020·2020-09-02
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2896-2020·2020-09-02
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2890-2020·2020-09-02
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2892-2020·2020-09-02
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2891-2020·2020-09-02
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2895-2020·2020-09-02
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
Medical Device
Distribution
Distributed nationwide