The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

6151–6175 of 88183

  • 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 (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-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 (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 (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 (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
  • 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 (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 (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
  • LowFDA (Drugs)·D-0669-2025·2025-10-01

    Dextroamphetamine Saccharate and Amphetamine Capsules Recalled for Failed Impurities Specifications

    Granules Pharmaceuticals Inc. is recalling 3,384 bottles of mixed-salt amphetamine extended-release capsules (5 mg) distributed nationwide due to failed impurities and degradation specifications.

    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
  • CriticalFDA (Devices)·Z-2538-2025·2025-09-24

    Wheelchair power assist speed dials recalled over potential loss of control

    SmartDrive MX2+ SpeedControl Dials are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. The FDA classified the action as Class I. 25,389 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Food)·H-0608-2025·2025-09-24

    Sliced peeled cucumbers in 10 lb boxes recalled over Salmonella contamination

    Cucumber Sliced PLD KBS in 2/10 lb cardboard boxes, code X3234937, is recalled because the product is contaminated with Salmonella. The FDA classified the action as Class I.

    Product
    Cucumber Sliced PLD ¿ KBS 2/10lb, Cardboard Boxes
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-2540-2025·2025-09-24

    SmartDrive speed control dials recalled over faulty motor electrical connection

    SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCMC, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 8,413 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Food)·H-0612-2025·2025-09-24

    Spanish club ciabatta sandwiches recalled over undeclared wheat and milk

    Spanish Club Ciabatta, 10.5 oz, from Fresh and Ready Foods is recalled for undeclared wheat and milk. The FDA classified the action as Class I. 233 units are affected.

    Product
    Spanish Club Ciabatta; Keep Refrigerated, NET WT: 10.5 OZ, UPC# 6 82906 90933 7 Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0618-2025·2025-09-24

    Frozen peas and carrots recalled over possible Listeria monocytogenes contamination

    Endico brand Peas & Carrots, 2.5 lb frozen bags produced 06/11/2025, are recalled because the product may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Endico brand PEAS & CARROTS; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook until tender. Season to taste and serve.; Cook to 165 F For Quality And Food Safety…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·H-0613-2025·2025-09-24

    Artichoke and mozzarella salad recalled over undeclared wheat and milk

    Tuscan Artichoke and Mozzarella Salad, 8.5 oz, from Fresh and Ready Foods is recalled for undeclared wheat and milk. The FDA classified the action as Class I. 233 units are affected.

    Product
    Tuscan Artichoke and Mozzarella Salad; Keep Refrigerated, NET WT: 8.5 OZ, UPC# 6 82906 90935 1 Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0582-2025·2025-09-24

    Belgian popping milk chocolates recalled because wheat is undeclared on label

    Neuhaus Original Belgian Chocolate popping milk chocolates with cookies, 4.23 oz, are recalled because the product contains undeclared wheat. The FDA classified the action as Class I.

    Product
    NEUHAUS brand ORIGINAL BELGIAN CHOCOLATE; POPPING MILK CHOCOLATES WITH COOKIES; 4.23 oz - 120g; (EN)Chocolates - INGREDIENTS: milk chocolate (sugar, whole milk powder, cocoa mass, cocoa butter, emulsifier: soy lecithin, flavour), sugar, sunflower oil, whole milk powder, cocoa…
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·H-0615-2025·2025-09-24

    Chili crunch mezze packs recalled over undeclared wheat in ready-to-eat sandwiches

    Chili Crunch Market Mezze, 14.5 oz, from Fresh and Ready Foods is recalled for undeclared wheat. The FDA classified the action as Class I. 233 units are affected.

    Product
    Chili Crunch Market Mezze; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0605-2025·2025-09-24

    Honey balsamic dressing pouches recalled over undeclared soy and sesame

    Honey Balsamic dressing in 3.4 ounce plastic pouches is recalled because it contains undeclared soy and sesame. The FDA classified the action as Class I. 46,800 units are affected.

    Product
    Honey Balsamic dressing, 3.4 ounce plastic pouch, Best by date and Lot number appear directly on pouch.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2539-2025·2025-09-24

    SmartDrive MX2-3DCK dials recalled over faulty connection to wheelchair motor

    SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCK, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 15,834 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states