Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

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.

3476–3500 of 52939

HighFDA (Drugs)·D-0667-2025·2025-10-01
Micronized benzoyl peroxide cleanser recalled over elevated benzene levels
Micronized BPO Gel Cleanser 10% from Pantea MD, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene. The product was distributed in California and Georgia.
Product
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2604-2025·2025-10-01
CT 6000 scanners recalled because the patient table may drop unexpectedly
Philips CT 6000 systems, model 728307, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 6 units are affected.
Product
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V658000·2025-10-01
2026 Tesla Model Y: Reverse Lights May Fail to Illuminate
Tesla is recalling certain 2026 Model Y vehicles because the reverse lights may fail to illuminate due to a wiring defect, which could reduce visibility when backing and increase crash risk.
Product
TESLA — TESLA MODEL Y
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2626-2025·2025-10-01
Allura Xper FD20 systems recalled over component deterioration halting motorized movements
Philips Allura Xper FD20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2,114 units are affected.
Product
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2025·2025-10-01
Philips Brilliance iCT SP CT Systems Patient Support Table Descent
Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2627-2025·2025-10-01
Allura Xper FD20 Biplane recalled over component deterioration affecting motorized movements
Philips Allura Xper FD20 Biplane systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 268 units are affected.
Product
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0624-2025·2025-10-01
Mai Tai 20mg CBD/THC Gummies Recalled for Peanut Protein Cross-Contact
Extract Labs, Inc. is recalling Mai Tai 20mg gummies due to potential peanut protein cross-contact. The affected product is unlabeled bulk gummies distributed throughout the United States and internationally.
Product
Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use: D
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-2598-2025·2025-10-01
Brilliance iCT systems recalled over ball screw misalignment dropping the couch
Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0623-2025·2025-10-01
Bulk blue razz gummies recalled over potential peanut protein cross-contact
Unlabelled bulk Blue Razz 20 mg gummies, lot 25JD082307A, are recalled because of potential peanut protein cross-contact. 19,810 gummies are affected.
Product
Blue Razz 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use:
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2625-2025·2025-10-01
Allura Xper FD10 OR Table recalled over ageing power supply and drive
Philips Allura Xper FD10 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2 units are affected.
Product
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2594-2025·2025-10-01
Intravenous solution sets recalled after customer reports of tubing separation
Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.
Product
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0665-2025·2025-10-01
Benzaderm BPO cleanser recalled over elevated benzene in benzoyl peroxide
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene.
Product
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Category
Drug
Distribution
2 states
HighFDA (Food)·H-0622-2025·2025-10-01
Elderberry Gummies Recalled for Potential Peanut Protein Cross-Contact
Extract Labs, Inc. is recalling Elderberry 20mg Gummies (Lot 25JD072107A) due to potential peanut protein cross-contact. Consumers should not use the product if they have a peanut allergy.
Product
Elderberry 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2606-2025·2025-10-01
MyDay toric contact lenses recalled after one lot used invalid sterilization
MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2025·2025-10-01
Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.
Product
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2595-2025·2025-10-01
Brilliance CT 40 and 64 channel systems recalled over unexpected couch descent
Philips Brilliance CT 40 Channel, Brilliance CT 64 Channel and Ingenuity Flex systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 181 units are affected.
Product
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2632-2025·2025-10-01
Allura Xper FD20/10 systems recalled over deterioration disabling motorized movement
Philips Allura Xper FD20/10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 45 units are affected.
Product
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2636-2025·2025-10-01
Vessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
Vasoview Hemopro 3 Endoscopic Vessel Harvesting Systems are recalled after out-of-box failures including deformed jaw attachments, jaws not fully closed and lifted heater wire. 98 units are affected.
Product
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2634-2025·2025-10-01
Allura Xper FD20/15 OR Table recalled over internal component deterioration
The Philips Allura Xper FD20/15 OR Table is recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. One unit is affected.
Product
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2025·2025-10-01
Sofmed Breathables contact lenses recalled over an invalid sterilization cycle
Sofmed Breathables contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 180 units are affected.
Product
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2025·2025-10-01
Ingenuity CT scanners recalled because the patient couch may descend unexpectedly
Philips Ingenuity CT systems are recalled because the patient support table may descend unexpectedly to its lowermost position due to ball screw misalignment after a replacement. 285 units are affected.
Product
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2623-2025·2025-10-01
Allura Xper FD10 systems recalled over ageing internal components stopping motorised movement
Philips Allura Xper FD10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 1,117 units are affected.
Product
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2596-2025·2025-10-01
Brilliance 16 and 6 slice scanners recalled over patient table descent
Philips Brilliance 16 Power, Brilliance CT 16 Slice and Brilliance CT 6 Slice systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 73 units are affected.
Product
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2630-2025·2025-10-01
Allura Xper FD20/20 systems recalled over battery, drive and power supply deterioration
Philips Allura Xper FD20/20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 75 units are affected.
Product
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0666-2025·2025-10-01
Mel Rx acne treatment recalled over elevated benzene in benzoyl peroxide
mel rx Skin NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene. The product was distributed in California and Georgia.
Product
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Category
Drug
Distribution
2 states