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.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post within the inner packaging, resulting in loose devices and coating debris.
Becton Dickinson is recalling Bard MyPICC Kits because they contain surgical gowns subject to a supplier recall.
Boston Scientific is recalling five AMS 700 100 mL Spherical Reservoirs with InhibiZone because they were incorrectly labeled as a different model.
Frito-Lay is recalling Ruffles Onion flavoured dip jars in the US and Canada due to potential mold contamination.
Frito-Lay is recalling Ruffles Ranch flavoured dip in 425 g glass jars sold in the US and Canada due to potential mold contamination.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in coating debris.
Capso Vision, Inc. is recalling 44 CapsoCam Plus video capsule systems because incorrect serial number labels may lead to patient misdiagnosis.
Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.
Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.
Dole Fresh Vegetables Inc is recalling Classic Kit Light Caesar salad kits due to a critical control point deviation involving low levels of chlorine in the wash process.
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.
Natural Dairy Products is recalling Natural by Nature 1% Milk due to a sample testing positive for antibiotic residue. The product was distributed to seven states.
Becton Dickinson is recalling 655 PowerGlide ST Midline Catheter Maximal Barrier Kits because they were packaged without the required lidocaine.
The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.
Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.
Natural Dairy Products is recalling Common Market 1% Milk (1/2 Gallon) because a sample tested positive for antibiotic residue.
ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.
Genicon is recalling 1,550 units of the EZee Single Use Specimen Retrieval Bag to provide updated labeling instructions for multiple specimen retrieval.
Karl Storz Endoscopy is recalling sterile insufflation tubing because it may contain higher ethylene oxide residues than the acceptable level.
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.
Medtronic is recalling 83 Vertex Select Multi Axial Screws because the product length is shorter than labeled. The recall covers units distributed in California and Michigan.
ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.
Cardiac Assist, Inc. is recalling five TandemHeart pump kits because an assembly error may prevent the device from priming.