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.
GE OEC Medical Systems is recalling 47 OEC UroView 2800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitor to appear dark with no video displayed.
Medtronic Sofamor Danek is recalling specific total knee replacement femoral components that may not have been passivated correctly.
GE OEC Medical Systems is recalling 47 OEC 9800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitors to appear dark with no video displayed.
Siemens is recalling two CT scanners where a software error prevents contrast agent injection during automatic scans, resulting in failed examinations.
Teva North America is recalling Amoxicillin for Oral Suspension because stability testing showed the drug was superpotent.
American National Mfg Inc is recalling 31 Panacea Air Pro Mattress Control Units due to a firmware problem that may affect the device's firmness range.
Philips is recalling 50 Brilliance CT 16 Power systems due to a software defect that may cause planned anatomy to be cut off in images, potentially requiring a rescan.
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated according to requirements.
Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.
Novus Scientific is updating instructions for use for TIGR Matrix Surgical Mesh regarding inguinal hernia repairs.
Stryker is voluntarily recalling 78 Neptune 3 Rover devices because electromagnetic interference may cause system errors and shutdowns.
Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.
Philips is recalling 283 Brilliance 64 CT scanners because a software update can cause planned anatomy to be cut off in images, potentially requiring a rescan.
Siemens is recalling four CT systems because a software error prevents the contrast agent injector from starting in automatic or coupled modes.
Siemens is recalling one SOMATOM Definition AS CT scanner because a software error prevents the automatic injection of contrast agent during scans.
Novarad Corporation is recalling NovaPACS software versions 8.4.7, 8.5.3, and 8.5.6 due to a prematurely released pop-up screen.
Medtronic is recalling Alpha total knee replacement femoral components that may not have been passivated according to job traveler requirements.
Merz North America is recalling 1,591 units of Radiesse (+) Lidocaine Injectable Implant because the product could not be expelled from the syringe or needle.
Integra LifeSciences is recalling QWIX Compression Screws because the product labeling incorrectly identifies them as compression screws rather than positioning screws.
Philips is recalling 24 Brilliance BigBore CT scanners because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.
Encore Medical is recalling 866 units of Cobalt HV Bone Cement because the outer packaging incorrectly indicated the product contained Gentamicin, an antibiotic it does not contain.
Northern Tier Bakery is recalling Cheese & Berries Danish pastries due to possible mislabeling and undeclared food colors Blue #1 and Red #40.
Sentry Foods is recalling approximately 21,570 pounds of frozen chicken entrées that may contain glass or hard plastic. The products were shipped to retail locations in Indiana, Texas, and Pennsylvania.
Biomet 3i is recalling specific Gingihue dental implants because their pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Titanium Temporary Cylinder Dental implants because pouches may not have been sealed during packing.