FDA (Devices) recall action 79779
The FDA (Devices) publishes a recall like this one as 11 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 11 pages.
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
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.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Stryker is recalling T4 Zipper Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a potential risk of exposure to contaminants.