Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Percussionaire Corporation is recalling 419 Intrapulmonary Percussive Ventilation (IPV) devices to update labeling warnings regarding the use of volatile anesthetic delivery systems.
Amneal Pharmaceuticals is recalling 2,592 cartons of Estradiol Gel 0.1% because some packets were found to be empty or partially full.
Illumina is recalling 80 NovaSeq 6000Dx and DRAGEN Server units worldwide due to a security vulnerability in the server component.
ASP Global is recalling 6,510 sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Percussionaire Corporation is recalling IPV-1C and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
ASP Global is recalling Expressaire disposable tourniquet cuffs due to incorrect expiration dates. The products were labeled with a 10-year shelf life, but the validated shelf life is 5 years.
Philips is recalling five SmartPath to MR 7700 units because diffusion tensor imaging exports contain incorrect data, preventing correct processing by third-party software.
Alere San Diego is recalling multiple hCG urine test strips because they may detect low hCG levels, resulting in false positive results.
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Beckman Coulter is recalling AU480 Chemistry Analyzers because a software error prevents the instrument from starting, delaying patient results.
ASP Global is recalling sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Olympus is recalling 50 units of the M3 Gold Autoclavable Lateral Telescope 70 in Japan due to discrepancies between sterilization parameters in the Instructions for Use and the Japanese package insert.
ASP Global, LLC. is recalling Expressaire disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
ASP Global is recalling Expressaire disposable tourniquet cuffs because they are labeled with a 10-year shelf life, but the validated shelf life is 5 years.
Shanghai United Imaging Healthcare is recalling one uMI 780 PET/CT system due to a software defect that may hide patient images, potentially requiring rescans.
ASP Global is recalling 360 MPR single-use tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Ajanta Pharma USA Inc. is recalling Ranolazine Extended-Release Tablets, 1000 mg, because the product failed to meet dissolution specifications.
ASP Global is recalling sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
Shanghai United Imaging Healthcare is recalling three uMI Panorama GS PET/CT systems due to a software issue that may hide patient images, potentially requiring rescans.
Philips North America is recalling 131 MR 5300 systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.
Alere San Diego, Inc. is recalling multiple hCG pregnancy test models because they may detect low hCG levels, resulting in false positive results.
ASP Global is recalling sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
Philips is recalling SmartPath MRI software because it exports incorrect diffusion tensor imaging data, preventing correct processing by third-party tractography software.
Philips is recalling 340 Ingenia MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate third-party processing.
Shanghai United Imaging Healthcare is recalling three uMI Panvivo PET/CT systems due to a software issue that may hide patient images, potentially requiring rescans.