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.
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Philips Medical Systems is recalling BrightView XCT gamma cameras because the CT portion of scans may be interrupted and fail to complete successfully.
Arrow International Inc is recalling specific lots of Continuous Nerve Block Components because the packaging incorrectly identifies the needle gauge. No injuries or illnesses have been reported.
Tristar Food Wholesale is recalling Bar Guo Preserved Plum Candy containing non-permitted cyclamates, undeclared benzoic acid, and undeclared Yellow #5.
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated conditions.
Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.
Fresenius Kabi is recalling 92,125 vials of Gentamicin Injection because some may be missing stoppers. The product was distributed nationwide and in Puerto Rico.
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Siemens is recalling 1,131 Artis zee and zeego Angiography Systems due to a software issue that prevents deactivating the radiation block function after a network problem.
Beevers Manufacturing recalled 393 units of Cannulaide Model 101 because the product was packed and labeled as Model 102.
Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped beyond their expiration dates.
Stryker Neurovascular is recalling Target Detachable Coils shipped to US customers beyond their expiration date.
Coca-Cola is recalling specific lots of Dasani purified water because an equipment malfunction may have caused mold to appear in some bottles.
Stryker Neurovascular is recalling GDC 360 coils and related devices shipped to US customers beyond their expiration dates.
Stryker Neurovascular is recalling Gateway PTA Balloon Catheters shipped to US customers beyond their expiration date.
Aesculap, Inc. is recalling three Dual Switch Valves due to incorrect expiration dates on inner sterile bag labels. No patient injuries have been reported.
Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets due to a formulation deviation. The affected products were distributed nationwide and internationally.
Amerx Health Care Corp. is recalling 79,677 Amerigel Post-op Surgical Kits due to a formulation deviation. The affected kits were distributed nationwide and internationally.
Sandoz, Inc. is recalling 6,336 bottles of 16 mg candesartan cilexetil tablets because stability testing showed impurity levels exceeded specifications.
Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing due to a formulation deviation. The products were distributed nationwide and internationally.
Microgenics Corporation is recalling 2,135 vials of MAS CardioImmune XL Cardiac Marker Control (Lot CXL16011) because the product shows vial-to-vial variation for specific analytes.
Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped to US customers beyond their expiration dates.
Intuitive Surgical is recalling 509 8mm Resano Forceps instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Biomerica is recalling Calcitonin ELISA Kits because they may produce false high values. The recall covers 1,062 units distributed worldwide.