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.

4451–4475 of 88106

  • HighFDA (Devices)·Z-0992-2026·2025-12-31

    Dialysis concentrate 100425 recalled because safety and efficacy cannot be assured

    Diasol is recalling 2200 gallons of liquid concentrate for bicarbonate dialysis, product 100425-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2026·2025-12-31

    Femoral nails, 320 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609320, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2026·2025-12-31

    Femoral nails, 380 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509380, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2026·2025-12-31

    Surgical robot console motors recalled over an error that locks ergonomics

    Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors because a connector fault triggers Error 23062 and locks console ergonomics until the motor is replaced.

    Product
    da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2026·2025-12-31

    Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609360, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2026·2025-12-31

    Digital radiography systems recalled over exceeding the maximum air kerma rate

    AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.

    Product
    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2026·2025-12-31

    Dialysis concentrate 100125 recalled because safety and efficacy cannot be assured

    Diasol is recalling 7,200 gallons of liquid concentrate for bicarbonate dialysis, product 100125-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0330-2026·2025-12-31

    Coffee cake recalled after maple walnut was labeled as raspberry

    The James Skinner LLC is recalling 811 cases of Publix Raspberry Coffee Cake because Maple Walnut Coffee Cake was incorrectly labeled as Raspberry and walnuts were not declared.

    Product
    Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear plastic clamshell lid with wraparound label, UPC 0-41415-54691-2, Distributed By Publix Supermarkets, Inc. Lakeland, FL 33802, packed 12 per case Case label reads, in part: Maple…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0977-2026·2025-12-31

    Neurostimulator programmer app recalled over a device reset message that persisted

    Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2026·2025-12-31

    Femoral nails, 300 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815509300, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2026·2025-12-31

    Femoral nails, 280 mm left piriformis, recalled over undersized shaft diameter

    Zimmer is recalling 3 Affixus Antegrade Femoral Nails, model 815809280, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2026·2025-12-31

    Bicarbonate reagent recalled over falsely high results from LDH interference

    Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.

    Product
    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2026·2025-12-31

    Dialysis concentrate 100230 recalled because safety and efficacy cannot be assured

    Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2026·2025-12-31

    Campylobacter LYFO DISK controls recalled over failure to recover the organism

    Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0994-2026·2025-12-31

    Transjugular access sets recalled over products manufactured out of specification

    Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

    Product
    Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0348-2026·2025-12-31

    Sinus Cap herbal capsules recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 38 bags of Sinus Cap Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Clay, 50 capsules/510 mg; packaged in a plastic bag
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0963-2026·2025-12-31

    Cranial tracker devices recalled over an error message preventing use

    Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.

    Product
    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0342-2026·2025-12-31

    Baby Soothe herbal supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 49 bottles of Baby Soothe Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottle
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·H-0340-2026·2025-12-31

    Anti-virus herbal supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 116 bottles of Anti-virus Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Anti-virus Herbal Supplement, 1:5 Alcohol Tincture, Helps to stop viral replication, expectorant properties, Contains: Forsethia blossoms, Sumac berries, Pine needles; packaged in a 2 oz. glass dropper bottle, UPC 283162814429
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·H-0343-2026·2025-12-31

    Boswellia herbal supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 278 bottles of Boswellia Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Boswellia Herbal Supplement, 1:5 Alcohol Double Extract, Extracted from Frankincense with powerful anti-inflammatory properties, useful for pain & inflammation; packaged in a 2 oz. glass dropper bottle, UPC 284260392420
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·H-0347-2026·2025-12-31

    Pain Away herbal supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 275 bottles of Pain Away Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Pain Away Herbal Supplement, Analgesic & anti-inflammatory properties, Wood Betony & White Willow in vegetable glycerin, packaged in a 4.5 oz. glass bottle or 9 oz. glass bottle, UPC 231946534537
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0985-2026·2025-12-31

    Campylobacter six-pack control kits recalled over failure to recover the organism

    Microbiologics is recalling 18 KWIK-STIK 6-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2026·2025-12-31

    Campylobacter control kits recalled because they may fail to recover the organism

    Microbiologics is recalling 86 KWIK-STIK 2-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0344-2026·2025-12-31

    Chaga mushroom supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 144 bottles of Chaga Mushroom Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper bottle, UPC 284588087831
    Category
    Food
    Distribution
    12 states