Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Good Karma Foods is recalling Trader Joe's Natural Creamer - Vanilla because the product contains milk but the label does not list it as an ingredient.
DePuy Orthopaedics is recalling CORAIL AMT COXA VARA Neck Segments because debris or material may be found behind the O-rings.
Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.
LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.
Glenmark Pharmaceuticals is recalling 2,076 bottles of Pravastatin Sodium 20 mg tablets because a foreign tablet was found in the product.
Becton Dickinson is recalling 6.5 million blood collection assemblies because the luer could break, causing leaks or blocking dialysis ports.
DePuy Orthopaedics is recalling CORAIL AMT High Offset Neck Segments because debris or material may be found behind the O-rings.
Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.
Thomas Hammer Coffee Roasters is recalling Peanut Butter Cookies because the label declared butter but failed to declare milk.
MTD is recalling about 5,000 Craftsman M350 walk-behind lawn mowers sold at Lowe's because sharp objects can pierce the collecting bag and strike users or bystanders.
Professional Compounding Pharmacy is recalling 12 prescriptions of Dexamethasone eye drops due to insanitary conditions observed during compounding.
Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.
Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.
Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.
Livin' Lite is recalling 2013-2017 Camplite and 2014-2017 Bearcat trailers because a manual awning arm may block an exit window, increasing injury risk during emergencies.
McDaniel Life-Line LLC is voluntarily recalling Life-Line Catalytic Activated Energy Water because it is an unapproved new drug. The product was distributed in the US and several international countries.
Professional Compounding Pharmacy is recalling PGE1-Lidocaine injectable products because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Procept Biorobotics is recalling 214 AquaBeam Handpieces because a micro-crack in a weld joint may cause an internal leak, potentially delaying or preventing the completion of medical procedures.
DePuy Orthopaedics is recalling CORAIL AMT Standard Offset Neck Segments because debris or material may be found behind the O-rings. These surgical instruments are used in hip arthroplasty.
Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.
Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.
Professional Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
Spencer Manufacturing is recalling certain 2017-2019 fire trucks because Whelen accessory brake lights may illuminate without the brake pedal being pressed.
Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.
Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.