The Recall Desk

Archive

October 2025 recalls

804 recalls were announced in October 2025.

What the numbers show

Critical
179
Severe
78
High
390
Moderate
154
Low
3

Of the 804 recalls this month scored against our rubric, 22% are Critical, 10% are Severe.

701–800 of 804

  • ModerateFDA (Devices)·Z-0010-2026·2025-10-08

    Allura Xper FD20/15 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 300 Allura Xper FD20/15 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2672-2025·2025-10-08

    Vital sign monitors recalled over blood pressure measurement error messages

    Schiller is recalling 266 Argus PB-3000 vital sign monitors that may trigger an error message during blood pressure measurement when initial inflation pressure is set high.

    Product
    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2026·2025-10-08

    Allura Xper FD20/10 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 87 Allura Xper FD20/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2026·2025-10-08

    Allura Xper FD10 OR Table systems recalled over BIOS battery depletion

    Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.

    Product
    Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-0641-2025·2025-10-08

    Frozen whiting fillets recalled after wrong best by date was printed

    NAFCO is recalling 141 cases of frozen whiting fillets because the retail bags carry a best-by date of 1-11-2025, implying the product is expired when it is good until 1-11-2027.

    Product
    NAFCO, WHITING FILLET SKIN-ON BONELESS IQF, 2 lb., Cases are corrugate. The product is individually frozen and packed in food contact retail bag. 15 bags per case. Keep Frozen
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·25V669000·2025-10-07

    2024-2026 LUCID AIR Vehicles Recalled for Drive Shaft Defect

    Lucid USA is recalling 225 2024-2026 LUCID AIR vehicles with Pure Rear-Wheel Drive due to improperly secured bolts that could cause the half-shaft to disconnect, increasing crash risk.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V668000·2025-10-07

    2025 Toyota Sienna Hybrid Recalled for Improperly Welded Seat Rails

    Toyota recalls 2025 Sienna Hybrid vehicles because improperly welded second-row seat rails may fail in a crash, increasing injury risk. Dealers will replace the rails free of charge.

    Product
    TOYOTA — TOYOTA SIENNA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V670000·2025-10-07

    2022-2025 Lucid Air Recalled for Rearview Camera Software Defect

    Lucid is recalling 2022-2025 Air vehicles due to a software defect that may prevent the rearview camera from displaying or show inaccurate images, increasing crash risk. A free over-the-air software update will be provided.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-10072025-01·2025-10-07

    FreshRealm Ready-to-Eat Meals Alerted for Listeria Contamination

    USDA FSIS issued a public health alert for FreshRealm ready-to-eat meals containing riced cauliflower that may be contaminated with Listeria monocytogenes.

    Product
    Freshrealm — FSIS Issues Public Health Alert For Ready-To-Eat Meals Containing Riced Cauliflower That May Be Contaminated With Listeria
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·25V667000·2025-10-07

    2020-2025 Alfa Romeo Giulia and Stelvio Vehicles Recalled for Rearview Camera Defect

    Chrysler is recalling certain 2020-2025 Alfa Romeo Giulia and Stelvio vehicles because a defect in the rearview camera system may prevent the camera image from displaying, increasing crash risk. Owners should contact dealers for free inspection and repair.

    Product
    ALFA ROMEO — ALFA ROMEO STELVIO, GIULIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V666000·2025-10-06

    Mack Trucks with Improperly Welded Seat Belt Anchorage Brackets

    Mack is recalling certain 2019-2025 MD, Anthem, Granite, and 2024 MD Electric and 2025 Pinnacle trucks with passenger bench seats. An improperly welded seat belt anchorage bracket may detach during a crash, increasing injury risk.

    Product
    MACK — MACK GRANITE (GR), MD, ANTHEM (AN), PINNACLE (PI/PN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-10062025-01·2025-10-06

    USDA Alerts on FreshRealm Ready-to-Eat Meals with Listeria-Contaminated Spinach

    USDA FSIS issued a public health alert for FreshRealm ready-to-eat meals containing spinach recalled for possible Listeria contamination. No illnesses have been reported.

    Product
    FreshRealm — FSIS Issues Public Health Alert For Ready-To-Eat Meals Containing Spinach That May Be Contaminated With Listeria
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·25V665000·2025-10-06

    2025 RAM PROMASTER Battery Electric Vehicles Loss of Drive Power

    Chrysler is recalling certain 2024–2025 RAM ProMaster battery electric vehicles due to software issues in the electric drive module that may cause loss of drive power, increasing crash risk.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·031-2025·2025-10-04

    Foster Poultry Farms Recalls Chicken Corn Dogs and Ground Turkey Sticks

    Foster Poultry Farms is recalling chicken corn dogs and ground turkey on a stick products due to possible wood contamination. Consumers should not eat these items.

    Product
    Foster Poultry Farms, LLC — Foster Poultry Farms, LLC Recalls Chicken Corn Dog and Ground Turkey on a Stick Products Due To Possible Extraneous Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V663000·2025-10-03

    Altec Recalls ST600 Vehicles Due to Electrical Fire Risk

    Altec is recalling 2022-2025 ST600 vehicles with auxiliary engines because overloaded electrical circuits may overheat and increase the risk of fire.

    Product
    ALTEC — ALTEC ST600
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V664000·2025-10-03

    Recreational vehicles recalled for propane hose damage and fire hazard

    REV is recalling 2024-2026 Fleetwood Fortis and Holiday Rambler Invicta RVs with theater seats because theater seat fasteners may have damaged propane hoses, creating a fire hazard.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD INVICTA, FORTIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26002·2025-10-02

    Lithium ion power banks recalled after two fires and one burn injury

    About 2,400 Kogalla power banks are being recalled after two reports of lithium-ion batteries overheating and catching fire, causing one minor burn injury and about $3,300 in property damage.

    Product
    BP125, BatPak 2F and BatPak 3F Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V659000·2025-10-02

    2024-2025 Hyundai Santa Fe starter motor terminal cover fire risk

    Hyundai is recalling 2024-2025 Santa Fe vehicles. The starter motor terminal cover may be improperly installed, causing electrical shorts that increase fire risk during crashes.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·26004·2025-10-02

    Ten drawer dressers recalled for tip over and entrapment hazards

    About 610 Gunaito 10-drawer dressers sold on Walmart.com are being recalled because they are unstable when not anchored to a wall and violate the STURDY Act stability standard.

    Product
    Gunaito 10-Drawer Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0626-2025·2025-10-01

    Organic gouda cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz, with a sell-by date of 2/13/2026, is recalled for potential Listeria monocytogenes contamination.

    Product
    Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz., packaged individually in plastic, packed 12 per case
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-2566-2025·2025-10-01

    Intubation trays recalled after laryngoscope handle lights failed to illuminate

    Medline is recalling 2,520 intubation and airway kits containing Flexicare BritePro Solo fiber optic laryngoscope handles because the light may fail to illuminate as intended.

    Product
    Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC01
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Food)·H-0028-2026·2025-10-01

    Macaroni and cheese cartons recalled nationwide for undeclared cashew allergen

    GOODLES is recalling 61,176 cartons of Here Comes Truffle creamy truffle flavored cheddar and shells because the product contains cashews that are not declared on the label.

    Product
    GOODLES HERE COMES TRUFFLE CREAMY TRUFFLE FLAVORED CHEDDAR AND SHELLS NET WT 6 OZ (170g) INGREDIENTS: GOODLES SHELLS (WHEAT FLOUR, CHICKPEA PROTEIN, WHEAT PROTEIN, NUTRIENTS EXTRACTED FROM [BROCCOLI, SPINACH, KALE, PUMPKIN, SWEET POTATO, SUNFLOWER SEED, CRANBERRY, CHLORELLA, MAIT
    Category
    Food
    Distribution
    37 states
  • CriticalFDA (Food)·H-0027-2026·2025-10-01

    Plant-based white cheddar spirals recalled over undeclared milk allergen

    GOODLES Vegan Is Believin' Plant-Based White Cheddar with Spirals, 5.25 oz, is recalled for undeclared milk. The FDA classified the action as Class I. 129,660 cartons are affected.

    Product
    GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SPIRALS NET WT 5.25 OZ (149g) INGREDIENTS: GOODLES SPIRALS (WHEAT FLOUR, CHICKPEA PROTEIN, WHEAT PROTEIN, NUTRIENTS EXTRACTED FROM [BROCCOLI, SPINACH, KALE, PUMPKIN, SWEET POTATO, SUNFLOWER SEED, CRANBERRY, CHLORELLA, MAIT
    Category
    Food
    Distribution
    37 states
  • CriticalFDA (Food)·H-0630-2025·2025-10-01

    Original Swiss cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Original Swiss Cheese, in 5 lb loaves and 2 lb deli bags with a sell-by date of 2/13/2026, is recalled for potential Listeria monocytogenes contamination.

    Product
    Middlefield Original Cheese Co-op Original Swiss Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced and packaged as 2 lb. deli bags and packed 5 bags per case
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0627-2025·2025-10-01

    Shredded mozzarella and provolone recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lb bags with a sell-by date of 9/3/2025, is recalled for potential Listeria monocytogenes contamination. 7,455 lbs are affected.

    Product
    Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lbs., packaged in a plastic bag, packed 4 bags per case
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0632-2025·2025-10-01

    Monterey jack and provolone loaves recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Monterey Jack and Provolone 5 lb loaves with a sell-by date of 2/13/2026 are recalled for potential Listeria monocytogenes contamination. 7,455 lbs are affected.

    Product
    1) Middlefield Original Cheese Co-op Monterey Jack, 5 lb., packaged as loaves wrapped in plastic and packed 8 loaves per case 2) Middlefield Original Cheese Co-op Provolone, 5 lb., packaged as loaves wrapped in plastic and packed 2 loaves per case
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0631-2025·2025-10-01

    Pepper jack cheese loaves recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, in 5 lb loaves and 2 lb deli bags, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    1) Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced and packaged as 2 lb. deli bags and packed 5 bags per case 2) Middlefield Origina
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0633-2025·2025-10-01

    Shredded mozzarella cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb bags with a sell-by date of 9/3/2025, is recalled for potential Listeria monocytogenes contamination.

    Product
    Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb., shredded in a plastic bag and packed 4 bags per case
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0664-2025·2025-10-01

    Skin MD Body Acne Cleanser recalled due to elevated benzene levels

    Skin MD by Dr Monika Kiripolsky Body Acne Cleanser (Benzoyl Peroxide 10%, 7 oz) is being recalled due to elevated levels of benzene discovered during post-market monitoring. Affected lots 58170A and 58172A with expiration date 09/2025 were distributed in California and Georgia.

    Product
    Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·25V656000·2025-10-01

    2025 Toyota Tacoma Driveshaft Defect Risks Steering Failure and Rollaway

    Toyota is recalling certain 2025 Tacoma and Tacoma Hybrid vehicles because the front driveshaft CV joint may deform and break, impairing steering and risking vehicle rollaway while parked.

    Product
    TOYOTA — TOYOTA TACOMA, TACOMA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2568-2025·2025-10-01

    Automated Impella Controller units recalled for pump performance risk

    Abiomed is recalling specific Automated Impella Controllers with defective Pump Driver Circuit Assemblies that may cause decreased pump performance or pump stop. The defect triggers Impella Failure or Impella Stopped Controller Failure alarms.

    Product
    Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Package
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·H-0625-2025·2025-10-01

    Sunrise Creamery Dilly Pickle Monterey Jack Cheese recalled for Listeria

    Middlefield Original Cheese Cooperative is recalling Sunrise Creamery Dilly Pickle Monterey Jack Cheese products due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, Pennsylvania, Wisconsin, and Texas.

    Product
    1) Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles, Net Wt. 6 oz., packaged individually in plastic, packed 12 per case, UPC: 810665011156 2) Sunrise Creamery Dilly Pickle Jack Monterey Jack Cheese with Dill Pickles, Net Wt. 1.25 LBS (567 g), packaged indivi
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·H-0628-2025·2025-10-01

    Middlefield Cheddar Cheese Recalled Due to Listeria Contamination Risk

    Middlefield Original Cheese Cooperative is recalling specific lots of All Natural Mild Cheddar Cheese and Shredded Cheddar Cheese due to potential contamination with Listeria monocytogenes.

    Product
    1) Middlefield Original Cheese Co-op All Natural Mild Cheddar Cheese, 5 lb., packaged as individual loaves wrapped in plastic, packed 2 loaves per case (distribution) or 8 loaves per case (retail) 2) Middlefield Original Cheese Co-op Shredded Cheddar Cheese, 5 lb., packaged in a
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2567-2025·2025-10-01

    Medline Medical Convenience Kits with Defective Laryngoscope Handles

    Medline Industries is recalling specific medical convenience kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles because the light fails to illuminate as intended, potentially affecting resuscitation and airway management procedures.

    Product
    Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Food)·H-0629-2025·2025-10-01

    Middlefield Original Cheese Smoked Cheddar Recalled for Listeria Contamination

    Middlefield Original Cheese Cooperative is recalling Smoked Cheddar 5 lb. loaves due to potential Listeria monocytogenes contamination. The recall affects products packed on August 14, 2025, distributed across OH, PA, WI, and TX.

    Product
    Middlefield Original Cheese Co-op Smoked Cheddar, 5 lb. loaves, packaged 8 loaves per case
    Category
    Food
    Distribution
    4 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
  • 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
  • HighNHTSA·25V657000·2025-10-01

    Toyota Tundra and Sequoia Hybrid rear visibility software defect recall

    Toyota is recalling 2022-2025 Tundra, Tundra Hybrid, and 2023-2025 Sequoia Hybrid vehicles due to a software error that may prevent the rearview image from displaying when in reverse, reducing driver visibility and increasing crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA HYBRID, TUNDRA, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2025·2025-10-01

    Insulin pump app recalled over defect in right-to-left language settings

    The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.

    Product
    t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2603-2025·2025-10-01

    Ingenuity CT Brazil family recalled over patient table descending to lowermost position

    Philips Ingenuity CT Family Brazil systems, model 728325, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 3 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2631-2025·2025-10-01

    Allura Xper FD20/20 OR Table recalled over deteriorating internal system components

    Philips Allura Xper FD20/20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 3 units are affected.

    Product
    Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2025·2025-10-01

    Philips CT Systems Patient Support Table May Descend Unexpectedly

    Philips is recalling certain CT systems because the patient support table may descend unexpectedly to the lowest position due to a component misalignment during replacement.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • 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-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 (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-2608-2025·2025-10-01

    Voyant daily toric contact lenses recalled over an invalid sterilization cycle

    Voyant 1-Day Premium Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 90 units are affected.

    Product
    Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium 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-2615-2025·2025-10-01

    Orthopedic inserter adapters recalled over weld breakage between pin and holder

    Ortoma Inserter Adapter OTD devices are recalled because of a weld breakage between the pin and the inserter holder. 261 devices are affected.

    Product
    Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2025·2025-10-01

    IQon Spectral CT recalled over ball screw misalignment lowering the couch

    Philips IQon Spectral CT systems, model 728332, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 81 units are affected.

    Product
    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
    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-2622-2025·2025-10-01

    Patient monitors recalled over potential activation of an abnormal alarm pause

    BeneVision N1 Patient Monitors are recalled because of the potential for activation of an abnormal alarm pause. 2,278 units are affected.

    Product
    BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q
    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-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-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-2629-2025·2025-10-01

    Allura Xper FD20 Biplane OR Table recalled over internal component deterioration

    Philips Allura Xper FD20 Biplane OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 5 units are affected.

    Product
    Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    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-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-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-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-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 (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 (Food)·H-0637-2025·2025-10-01

    Bulk granulated sugar recalled over potential contamination with foreign objects

    Pure Cane Granulated Sugar in 50 lb bags, distributed by Domino Foods, is recalled because of potential contamination with foreign objects. 4,500 bags are affected.

    Product
    PURE CANE GRANULATED SUGAR, NET WT 50 LB (22.67kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705, STORE IN A COOL, DRY PLACE
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0621-2025·2025-10-01

    CBD and THC gummies recalled over potential peanut protein cross-contact

    Extract Labs Sugar-free Mixed Berry Gummies, lot 25E5082907A, are recalled because of potential peanut protein cross-contact. 2,180 gummies in 109 bottles are affected.

    Product
    Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D9 THC per gummy Dosage: 1 gummy Form: Gummy Administration: Oral Intended use: Dietary Supplement Type of packaging: 225cc amber packer bottle with child-re
    Category
    Food
    Distribution
    0 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 (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 (Drugs)·D-0668-2025·2025-10-01

    Benzoyl peroxide cleanser recalled after elevated benzene levels were found

    edunn clarity BP Treatment Cleanser 10%, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene. The product was distributed in California and Georgia.

    Product
    edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0663-2025·2025-10-01

    Artisan of Skin acne treatment recalled over elevated benzene levels

    Artisan of Skin Benzoyl Peroxide 10%, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene. 125 units distributed in California and Georgia are affected.

    Product
    ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2597-2025·2025-10-01

    Big Bore CT systems recalled because patient table may descend unexpectedly

    Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
    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 (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 (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 (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 (Devices)·Z-2635-2025·2025-10-01

    Allura CV20 systems recalled over internal component deterioration disabling motorized movement

    Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.

    Product
    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0662-2025·2025-10-01

    Azelaic acid gel recalled after complaints of gritty texture in tubes

    Glenmark Azelaic Acid Gel, 15%, 50 gram tubes from batch 19252524, is recalled nationwide after market complaints of a gritty or grainy texture. 13,824 tubes are affected.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2025·2025-10-01

    Amphetamine extended-release capsules 10 mg recalled over failed degradation specifications

    Mixed amphetamine salts extended-release capsules, 10 mg, lot GPC250159A, are recalled nationwide after failing impurities and degradation specifications. 11,895 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0634-2025·2025-10-01

    Donor human milk recalled over a potential physical contaminant in one batch

    MMBAL pasteurized donor human milk, 100 mL bottles from batch 001868-3, is recalled because of a potential physical contaminant. 25 bottles distributed in Alabama are affected.

    Product
    MMBAL pasteurized donor human milk (PDHM), 100 mL (3.38 fl. oz.), packaged in a BPA-free plastic bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2620-2025·2025-10-01

    Surgical light systems recalled over powder coating stress lines and chipping

    Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.

    Product
    Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2025·2025-10-01

    Philips Allura Xper FD10/10 X-Ray System Motorized Movement Failure Recall

    Philips Allura Xper FD10/10 X-ray systems may lose motorized movement capability due to deterioration of internal components including the CMOS battery, hard disk drive, or power supply unit. Imaging and manual movements remain functional.

    Product
    Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0660-2025·2025-10-01

    Isopropyl alcohol cans recalled for cross contamination with other products

    Kroger is recalling 1,860 bottles of its 70% Isopropyl Alcohol, 5.5 oz, from a single lot because of cross contamination with other products.

    Product
    70% ISOPROPYL RUBBING ALCOHOL — 70% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2025·2025-10-01

    Alcohol prep pads recalled over current good manufacturing practice deviations

    Quick Touch Alcohol Prep Pads containing 70% isopropyl alcohol, lot 20240610, are recalled for current good manufacturing practice deviations. 500 cases are affected.

    Product
    Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0672-2025·2025-10-01

    Amphetamine extended-release capsules 20 mg recalled over impurity and degradation results

    Mixed amphetamine salts extended-release capsules, 20 mg, lot GPC250179A, are recalled nationwide after failing impurities and degradation specifications. 11,909 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2025·2025-10-01

    FilmArray NGDS Warrior Panel diagnostic test system recall notice

    Biofire Defense is recalling the FilmArray NGDS Warrior Panel due to increased risk of internal control failures when testing positive blood cultures, which may delay results and require additional diagnostic evaluation.

    Product
    FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2025·2025-10-01

    Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration

    Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2619-2025·2025-10-01

    Soft tissue anchors recalled after cartons packed with wrong device size

    Zimmer Biomet is recalling JuggerKnot Mini Soft Anchors after outer cartons labeled for the 1.0mm Mini product were found to contain 1.4mm Short devices instead.

    Product
    Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2605-2025·2025-10-01

    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device recalled

    Ethicon LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot 104DBB) due to potential barb non-engagement that could affect surgical outcomes.

    Product
    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0673-2025·2025-10-01

    Amphetamine extended-release capsules 30 mg recalled after failing impurity specifications

    Mixed amphetamine salts extended-release capsules, 30 mg, lot GPC250181A, are recalled nationwide after failing impurities and degradation specifications. 11,928 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0671-2025·2025-10-01

    Amphetamine extended-release capsules 15 mg recalled after impurity testing failure

    Mixed amphetamine salts extended-release capsules, 15 mg, lot GPC250178A, are recalled nationwide after failing impurities and degradation specifications. 9,917 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide

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