FDA (Devices) recall action 98415
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
Potential for attenuation degradation over time, decreasing the lifespan.
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.
Burlington Medical is recalling BAT (Breast, Axilla and Thyroid) Coverage because of the potential for attenuation degradation over time.
Burlington Medical is recalling leg wraps because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Burlington Medical is recalling kilts made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Burlington Medical is recalling half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Burlington Medical is recalling protective vests because of the potential for attenuation degradation over time, decreasing the lifespan of the garment.
Burlington Medical is recalling kilt blockers because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Burlington Medical is recalling protective sleeves made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Burlington Medical is recalling frontal aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Burlington Medical is recalling demi half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Burlington Medical is recalling thyroid shields over the potential for attenuation degradation over time, which decreases the product's usable lifespan. 41,962 units are affected.
Burlington Medical is recalling blockers because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Burlington Medical is recalling wrap aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Burlington Medical is recalling protective caps made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.