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.
Philips Ultrasound, Inc. is recalling Philips C5-2 Transducers because they were refurbished beyond their useful life. The affected devices were distributed domestically nationwide and internationally across 49 countries.
Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.
Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.
Philips Ultrasound, Inc. is recalling 5,230 Philips L12-4 ultrasound transducer devices that were refurbished beyond their useful life. Affected units were distributed domestically and to numerous countries worldwide.
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.
The Harvard Drug Group LLC is recalling 23,232 cartons of Gabapentin Capsules 100 mg (Lot# M05205, Exp Date 10/2026) distributed nationwide due to inadequately sealed blister packaging that may compromise product integrity.
Philips Ultrasound, Inc. is recalling Philips XL14-3 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety during ultrasound examinations.
Autocar is recalling 2012-2025 Xspotter vehicles because incorrect tire inflation labels may lead to under-inflated tires, increasing crash risk.
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.
Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.
Protrim Plus dietary supplement 90-capsule bottles contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules. The product was distributed nationwide and may pose a risk to consumers with dye sensitivities or allergies.
Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.
NatureMills US Incorporated is recalling Nature Mills Sesame Rice Mix, 200g, due to undeclared milk. The product was distributed in the USA via the firm's website.
Preventics, Inc. is recalling Prothin dietary supplement packets because they contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules, which may affect consumers with dye sensitivities or allergies.
Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.
Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.
East Africa Boutique, LLC is recalling Nootri Toto (1 kg packages) distributed to seven retailers in Indiana, Kentucky, Missouri, and Ohio due to products being held under insanitary conditions.
Element 112, LLC is recalling Madeline's Patisserie Raspberry Croissants because they contain undeclared wheat, a major allergen. The recall affects approximately 194 cases distributed to four distributors in Michigan and Ohio.
Carley's Inc. is recalling Soft Baked Iced Lemon Cookies because the label incorrectly identifies an artificial yellow color instead of listing it as FD&C Yellow #5 as required.
East Africa Boutique, LLC. is recalling Super Cereal Plus fortified corn soya blend (1.5 kg bags) distributed to retailers in four states because the products were held under insanitary conditions.
Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.
Preventics, Inc. dba Legere Pharmaceuticals is recalling Super ProTHIN Plus dietary supplement because gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food colorings.
Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.
Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.
Big O' Smokehouse is recalling 4lb and 8oz containers of Whitefish Spread due to white plastic fragments found in the product. The affected spread was distributed to retail stores and distributors in Michigan and Illinois.