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.
Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.
CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.
Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.
AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.
The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.
Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.
Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.
Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.
Garden of Life RM-10 ULTRA dietary supplement recalled for undeclared soy. Approximately 8,940 bottles were distributed domestically and internationally.
Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.
Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.
Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.
Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.
KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.
KinderFarms is recalling approximately 376,370 bottles of Infants' Pain and Fever acetaminophen oral suspension nationwide due to failures in impurity and degradation specifications.
Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.
BAPS Shayona Bundi Ladoo was recalled because it contains undeclared artificial food dyes: Yellow 5, Red 40, and Green 3.
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.
BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
STAQ Pharma is recalling ROPivacaine HCl 0.2% injection bags nationwide due to leaking bags caused by manufacturing quality control failures. No illnesses or injuries have been reported.
Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.
Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.