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.
DeRoyal Industries has voluntarily recalled 90 kits of laminectomy spinal fusion surgical packs. The recall affects units distributed across 23 U.S. states. The specific reason for recall was not disclosed in available materials.
DeRoyal Industries initiated a voluntary recall of its Shoulder Arthroscopy Pack (32 kits, Lot 56865450) distributed to healthcare facilities in 23 U.S. states. The specific reason for recall is not disclosed in FDA documentation.
DeRoyal Industries initiated a recall of its POSTERIOR LAMI MICRODISC PACK, an FDA Class II medical device. The reason for this recall was not disclosed in available documentation.
Neuroquell Plus, a homeopathic calendula oil drug, has been voluntarily recalled due to current good manufacturing practice (cGMP) deviations. The recall affects 461 bottles distributed nationwide and in Australia.
Crate and Barrel is recalling about 280 Thornhill baby cribs because mattress support pins can become loose or not fit properly, causing the mattress to fall. The firm received six reports of the mattress support pins not fitting correctly or falling out, though no injuries have been reported.
Gabriella White LLC (Gabby Home) is recalling approximately 930 D-Ring Fritz wall mirrors because the hanging mechanism can fail, causing the mirror to detach and fall from the wall. No injuries have been reported, but seven detachment incidents have occurred.
CareFusion is recalling the V. Mueller Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, and maintenance procedures.
Carefusion is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.
Qvella is correcting documentation for the FAST System, a blood culture sample preparation device, because it exceeded its original regulatory scope. The company is updating manuals and promotional materials to clarify approved applications.
Carefusion is recalling 259 surgical bipolar forceps units because the Instructions for Use are missing critical information about power supply interface and maintenance procedures.
Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.
Randox Laboratories updated its carryover avoidance protocol for IgA and IgM immunoturbidimetric assays. Running these assays immediately after Fructosamine tests on RX instruments can cause falsely elevated results (up to +13% for IgA, +51% for IgM).
Medical Action Industries is recalling Port Access Kits that are incorrectly labeled as IV Start Kits on the individual kit label. The case label is correct; mislabeling could cause confusion about the product's identity.
Carefusion is recalling the V. Mueller Jewelers Bipolar Forceps due to incomplete Instructions for Use missing power supply interface and cleaning/maintenance instructions. The recall affects 236 units distributed nationwide and internationally.
CareFusion bipolar forceps (REF F-5061) recalled due to incomplete Instructions for Use missing device power supply interface and cleaning instruction content.
CareFusion bipolar surgical forceps recalled for incomplete Instructions for Use. Documentation is missing information on power supply interface and cleaning procedures.
Carefusion is recalling bipolar forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning procedures.
Carefusion recalled certain bipolar forceps due to incomplete Instructions For Use. The IFU was missing content about the device's power supply interface and cleaning and maintenance procedures.
Carefusion V. Mueller bipolar forceps are recalled because their instructions are missing information on power supply interface and cleaning procedures. Users should obtain the complete manufacturer instructions.
CareFusion is recalling bipolar forceps units due to incomplete instructions for power supply interface and device maintenance. The recall affects devices distributed worldwide.
CareFusion initiated a voluntary recall of bipolar forceps surgical instruments. The recall affects 4 units distributed nationwide and internationally.
CareFusion bipolar forceps are being recalled due to missing Instructions for Use content about power supply interface, cleaning, and maintenance. Users should obtain the complete manufacturer instructions immediately.
Betty Buzz LLC is recalling Betty Buzz Sparkling Grapefruit non-alcoholic beverage nationwide due to detected off-odor in the product. The recall affects 939 cases containing 22,536 bottles.
Carefusion recalls bipolar forceps due to incomplete Instructions for Use missing power supply interface and maintenance guidance. No injuries reported.
CareFusion bipolar forceps are recalled due to incomplete manufacturer instructions for use. Missing content covers power supply interface and device maintenance and cleaning procedures.