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.
Philips North America is recalling 7 GYROSCAN T5 MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create a safety risk during patient table use.
Eli Lilly & Company has voluntarily recalled 700 vials of Humalog sterile diluent due to Current Good Manufacturing Practice (CGMP) deviations. The affected batch (D608951C, exp. 4/10/2025) was distributed nationwide.
Shearer's Foods is recalling Great Value Twist & Shout Strawberry Creme Sandwich Cookies due to possible plastic fragments in the product. Affected items have a best-if-used-by date of September 11, 2024.
Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.
Philips is recalling 2,242 Ingenia 1.5T Magnetic Resonance Systems due to potential incorrect installation of the patient support table floor plate.
Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.
Philips Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.
Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.
Philips has recalled 143 Ingenia 1.5T CX MRI systems due to potential incorrect installation of the patient support table floor plate affecting worldwide distribution.
Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.
Philips is recalling 344 Ingenia Ambition S MRI systems because the patient support table floor plate may be incorrectly installed.
Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.
Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.
Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.
Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.
Smiths Medical syringe pumps with defective barrel clamp guides may fail to recognize or correctly identify loaded syringes, potentially affecting medication delivery accuracy.
Philips has recalled Intera 1.5T Achieva Nova-Dual MRI systems due to incorrect installation of the patient support table floor plate. The recall affects 20 units distributed worldwide.
Philips is recalling 49 Achieva XR magnetic resonance imaging systems worldwide due to an incorrectly installed patient support table floor plate that may affect equipment stability and patient safety.
Baxter Healthcare is recalling marketing brochures for surgical vessel occluders and related devices because the brochures contain information that does not match the official product instructions for use.
Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Philips is recalling one Achieva 3.0T for PET MRI system with a patient support table floor plate that may be incorrectly installed.
Canadian Art Prints is recalling Tranquility & Teachings plate sets that may exceed FDA guidance levels for leachable lead. The recall affects 83 boxes distributed across 14 U.S. states.
Philips is recalling 448 Ingenia Elition X MRI systems worldwide due to potentially incorrect installation of the patient support table floor plate, which could compromise structural integrity.