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.
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 bipolar surgical forceps recalled for incomplete Instructions for Use. Documentation is missing information on power supply interface and cleaning procedures.
Carefusion is recalling bipolar surgical forceps due to incomplete Instructions for Use. The missing instructions cover power supply interface and cleaning procedures.
CareFusion initiated a voluntary recall of bipolar forceps surgical instruments. The recall affects 4 units distributed nationwide and internationally.
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 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 are being recalled because their instruction manual is missing critical information about power supply interface and cleaning procedures. BD is providing corrected instructions to healthcare facilities.
Carefusion is recalling bipolar forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning procedures.
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 Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, and maintenance procedures.
Carefusion is recalling 259 surgical bipolar forceps units because the Instructions for Use are missing critical information about power supply interface 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.
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.
The Life is Good Company is recalling approximately 750 Fall 2022 Darkest Blue fleece sweatshirts and men's shorts that fail to meet federal flammability standards for clothing textiles, posing a risk of burn injuries.
Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.
Coolhaus Dairy Free Cookie Dough Lyfe frozen dessert sandwiches recalled due to coliform detected in lab samples. Product distributed to select retailers in Texas, Maryland, Colorado, and California.
Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.
Busse Hospital Disposables is recalling 40 cases of Busse Spine Injection Trays containing 3M Steri-Drape Surgical Drapes distributed in Texas due to a defective adhesive liner that is difficult to remove without damaging the product.
Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because testing found the drug out of specification for potency at shelf-life expiration. 528 cartons distributed nationwide are affected.
Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.
Dr. Reddy's Laboratories is recalling Allergy Relief D extended-release tablets distributed nationwide by Walmart due to failed dissolution specifications. No illnesses or injuries have been reported.
A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.
3M is recalling Steri-Drape Surgical Drapes because the liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable.
Target is recalling Cloud Island 4-Piece Plush Toy Sets because the tires on the toy vehicles can detach, posing a choking hazard to children. The firm has received four reports of tires detaching but no injuries have been reported.