PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Allura Xper FD. Model Numbers: 722026, 722027, 722028 recall — FDA Z-2928-2026
Firmware issue potentially leading to loss of geometry movements.
Complete FDA and NHTSA recall records dated in August 2026.
These records include useful source details for the selected month.
Firmware issue potentially leading to loss of geometry movements.
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced…
Due to an increase rate of balloon pinhole defects.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if…
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lack of assurance of sterility. The recall is due to potential contamination
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.