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.
Shimadzu Medical Systems is recalling 39 SONIALVISION G4 X-ray TV Systems due to a potential oil leak from the x-ray tube housing.
Biomet 3i is recalling 50 units of Low Profile Abutments because some pouches may not have been sealed during packaging.
Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths due to CGMP deviations and potential contamination on shared equipment.
Amendia, Inc. is recalling 25 Zeus-P Lumbar Interbody Devices because three boxes had conflicting patient and primary labels.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Ultroid Technologies is recalling 7,784 sterile disposable probes because they were not manufactured under required quality system controls.
Brownwood Farms is recalling Jalapeno Cherry Butter because it contains Yellow #5, an ingredient not declared on the label.
Biomet 3i is recalling 150 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Brownwood Farms is recalling Apple Riesling Salsa because it contains Yellow 5, an ingredient not declared on the label.
Inventia Healthcare is recalling Duloxetine Delayed-Release Capsules 30 mg because capsule shells were found opening inside the bottles.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
PerkinElmer is recalling 20ul Clear RoboRack Tips used with the JANUS Automated Workstation because they may dispense volumes 50-100% lower than specified.
Brownwood Farms is recalling Peach Salsa because it contains Yellow 5, a color additive not declared on the label.
Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components due to packaging punctures reported by customers.
Teleflex Medical is recalling RUSCH Pocket PAC Intermittent Catheter Kits because they are labeled with expiration dates that exceed the validated shelf life.
AngioDynamics is recalling 162 boxes of Stiffened Micro-Introducer Kits because the rotating luer may detach from the dilator hub during use.
Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Short due to punctured packaging.
Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth due to CGMP deviations and potential contamination. The product was distributed nationwide and internationally.
Teleflex Medical is recalling LMA MADgic atomization devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Biomet 3i is recalling 525 low-profile dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Owens & Minor is voluntarily recalling specific lots of Medi Choice Arm Slings due to surface contamination identified through customer complaints.
Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging reported by customers.
Teleflex Medical is recalling LMA MADomizer devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Biomet 3i is recalling a limited number of dental implant abutments because some product pouches may not have been sealed during packaging.