FDA (Devices) recall action 90848
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
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.
Baxter Healthcare is recalling the Allen Life Assist Beach Chair due to adhesive on fasteners that may not cure correctly, potentially compromising the device's mechanical integrity during surgical procedures.
Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.
Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.
Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.
Baxter Healthcare is recalling Simple Clamp surgical positioning equipment because the adhesive may not cure properly, reducing mechanical integrity during use. Affected units were distributed across multiple US states and international locations.
Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.