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.
Medline Industries is recalling 1-ounce medicine cups because the 10 mL increment is incorrectly printed as 5 mL, creating a risk of medication dosing errors.
Nobel Biocare is recalling 231 Guided Surgery Kits because the Instructions for Use contain an incorrect drill protocol. The kits are used for NobelParallel CC Implants.
Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may confuse users.
Philips Medical Systems is recalling 335 Brilliance iCT units due to software issues in versions v4.1.3 and v4.1.5 that could affect equipment performance.
Siemens is recalling AXIOM Artis angiography systems because biomass contamination in the cooling system may damage the pump.
Philips Medical Systems is recalling 203 Brilliance 16 CT systems due to a software defect causing intermittently slow response of the Host.
Philips Medical Systems is recalling 55 Brilliance CT 16 Power systems due to a software defect causing intermittently slow response of the Host.
Isomeric Pharmacy Solution is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension due to potential drug clumps and larger particle sizes.
Beckman Coulter is recalling AU480 Chemistry Analyzers because leaking C cups can cause coolant to short-circuit the instrument's circuit boards.
Beckman Coulter is recalling AU5800 Chemistry Analyzers because cracked C cups can leak coolant onto circuit boards, causing short-circuits and instrument stop mode.
Zimmer Surgical Inc is recalling 90 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.
Dako Denmark A/S is recalling 147 kits of EnVision FLEX+ Mouse, High pH (Link) because the Target Retrieval Solution has an incorrect pH level.
Merge Healthcare is recalling Merge PACS 6.0 software because it fails to display annotations on certain loaded studies.
B-K Medical A/S is recalling six bk3500 ultrasound systems because the generic volume measurement function may display incorrect calculations, potentially affecting diagnostic accuracy.
Zimmer Surgical Inc is recalling 70 units of Air Dermatome II Width Plates because the surface coating is blistering, peeling, and discoloring after use.
Zimmer Surgical Inc is recalling 220 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.
Medtronic Navigation is voluntarily recalling 27 units of StealthStation software due to compatibility issues with specific floor-based scanners.
Medtronic Navigation is conducting a voluntary field action for Synergy Cranial S7 software applications due to compatibility issues with specific floor-based scanners.
Roche Diagnostics is voluntarily recalling Vancomycin assay kits because method sheets contain incorrect comparison data for specific analyzers.
Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Zimmer Surgical Inc is recalling 60 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.
Mentor Texas, LP is recalling 35 units of 300cc MemoryGel Breast Implants because the boxes were labeled with null manufacturing and expiration dates.
Sam Kane Beef Processors is recalling approximately 60,350 pounds of Hill Country Fare ground beef products due to possible metal contamination.
AccessClosure is recalling 70 MynxGrip Vascular Closure Devices shipped with improper transport and packaging configurations.
Zimmer Surgical Inc is recalling 630 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.