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 Healthcare is recalling 13 Revolution CT scanners to perform a required torque check on three bolted joints. No injuries or illnesses have been reported.
Biomet Spine is recalling 15 Anchored Lateral Retractable Drills because the shaft diameter is oversized, causing interference when inserted into sleeve assemblies.
Biocare Medical is recalling three lots of MUM-1 antibody because staining intensity drops over time, potentially affecting diagnostic accuracy.
Biomet Spine is recalling 14 Timberline Anchored Lateral Fixed Retractable Sleeves because the inner diameter is undersized, causing interference fit when inserting instruments.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.
Siemens Medical Solutions is recalling 44 Artis zee/zeego angiography systems because the small focus of the x-ray tube may fail, causing a short interruption in procedures.
Ziemer USA Inc. is recalling 26 Femto LDV Z-Generation femtosecond surgical lasers because they were not shipped with the required Starter Kits.
SCA Pharmaceuticals is recalling 972 syringes of Glycopyrrolate injection distributed in Louisiana because a printing error made the expiration date appear incorrect.
NatureBox, Inc. is recalling Sweet Blueberry Almonds because the product label failed to list soy lecithin, an ingredient included in the recipe.
GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because their accuracy may exceed the design specification of +10%.
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.
Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.
GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because the accuracy of the x-ray tube potential and current may exceed the manufacturer's specified limits.
Stelkast Co is recalling 553 EXp Tibial Inserts because a missing lead-in radius may make it difficult to lock the inserts into tibial trays.
Centurion Medical Products is recalling 760 Diagnostic Imaging Trays due to a confirmed report of human hair embedded in a stopper.
Actavis Elizabeth LLC is recalling specific lots of Gabapentin 400 mg capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.
Baxter Healthcare is recalling HomeChoice and HomeChoice Pro Automated Peritoneal Dialysis systems because the patient guide lacks updated warnings and cautions.
Qualitest Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate Oral Solution because they failed impurity specifications for p-Aminophenol.
Exactech, Inc. is voluntarily recalling 96 Optetrak femoral implants due to mislabeling. The devices were distributed internationally to 13 countries.
McKesson Israel Ltd. is recalling McKesson Cardiology ECG Management software versions 13.1 and 13.1.1 because a software error causes incorrect ECG procedure time stamps.
Aurobindo Pharma USA Inc is recalling 24,816 bottles of Gabapentin 300 mg capsules nationwide because of complaints that the capsules were empty.
Centurion Medical Products is recalling 480 Nerve Block Trays due to a confirmed report of human hair embedded in a stopper.
Steris is recalling 140 Harmony vLED Surgical Lighting Systems because LED modules may illuminate inconsistently. The units were distributed worldwide.
CSA Medical is recalling 46 truFreeze cryogenic surgical devices because the timer may lose its audible sound, potentially affecting surgical procedures.