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.
Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
Stryker is recalling AutoPlex System kits because the piston head may separate, blocking the valve and causing cement backflow toward the injector handle.
Biomet 3i, LLC is recalling Locator Replacement Males dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance Post Dental implants because pouches may not have been sealed during packing.
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Blade Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
MicroPort Orthopedics is recalling 14 units of Profemur Modular Necks due to a labeling error where item numbers were incorrectly assigned.
Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.
Medtronic is recalling 6,720 Valleylab Laparoscopic Straight Spatula Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Hitachi Medical Systems America is recalling 33 Scenaria CT systems because centrifugal force may cause the power supply to fail, potentially requiring patients to be rescanned.
Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.
Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.
Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.
Philips is recalling Brilliance 64 CT scanners due to software issues that could affect equipment performance.
Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.
Siemens Medical Solutions is recalling 51 Artis zee and Artis Q angiography systems due to a software error that may cause image loss after startup.
Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.
Philips is recalling 899 MX 16-slice CT systems due to software defects that may cause patient image mix-ups or scan interruptions.
Siemens is recalling AXIOM Artis angiography systems because biomass contaminants in the cooling system may damage the pump.
Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may cause confusion during oxygen flow monitoring.
Nutritional Resources Inc. is recalling Healthwise Protein Chips because foreign plastic was observed in the product.
Topcon Medical Laser Systems is recalling 205 PASCAL Synthesis ophthalmic laser systems worldwide due to a software anomaly affecting the titration process when specific functions are used.
Philips Medical Systems is recalling 318 Brilliance 64 Computed Tomography X-ray systems due to a software defect causing intermittently slow response of the Host.
Philips Medical Systems is recalling 29 Ingenuity Core CT systems due to a software defect causing intermittently slow response of the Host.
Siemens Medical Solutions is recalling Artis Q and Q.Zen angiography systems because biomass in the cooling system may damage the pump.