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.

3176–3200 of 88106

  • HighFDA (Devices)·Z-1787-2026·2026-04-15

    Cook Medical nitinol stone extractors labeled with overstated expiration dates

    Cook Medical is recalling NCompass Nitinol Stone Extractors because affected lots were labeled with expiration dates that exceed the product's true shelf life. 70 units are affected.

    Product
    COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1776-2026·2026-04-15

    Cook Medical micro wire guides labeled with overstated expiration dates

    Cook Medical is recalling Approach CTO-12 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.

    Product
    COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0472-2026·2026-04-15

    Teva clonidine transdermal patches recalled over unapproved raw material use

    Teva is recalling two lots of Clonidine Transdermal System, USP, 0.1 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 124,054 cartons are affected.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·H-0658-2026·2026-04-15

    Olive skewers recalled for containing the banned sweetener cyclamates

    Olive Skewers imported by MEI YU CHENG DA TRADING are being recalled because the product contains cyclamates, a sweetener not permitted in food in the United States.

    Product
    Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar, monosodium glutamate, licorice, cloves, food additives (citric acid, DL malic acid, saccharin, sodium saccharin, steviol glycosides, aspartame, vanillin…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0474-2026·2026-04-15

    Teva clonidine 0.3 mg patches recalled over unapproved raw material use

    Teva is recalling three lots of Clonidine Transdermal System, USP, 0.3 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 113,943 cartons are affected.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0473-2026·2026-04-15

    Teva clonidine 0.2 mg patches recalled over unapproved raw material use

    Teva is recalling two lots of Clonidine Transdermal System, USP, 0.2 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 62,136 cartons are affected.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1775-2026·2026-04-15

    Cook Medical Micro Wire Guides Recalled Due to Incorrect Expiration Dates

    Cook Incorporated is recalling specific lots of COOK MEDICAL Approach CTO-6 Micro Wire Guides because they were labeled with expiration dates that exceed their actual shelf life.

    Product
    COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0657-2026·2026-04-15

    Dadi Nongfu dried salt chilli vegetables contain the banned sweetener cyclamates

    Dadi Nongfu Dried Salt Chilli Vegetables are being recalled because the product contains cyclamates, a sweetener not permitted in food in the United States.

    Product
    DADI NONGFU DRIED SALT CHILLI VEGETABLE(S); Ingredients: Radish, chili, roasted sesame, prickly ash, edible salt, soybean oil, edible vinegar, white granulated sugar, spices, food additives (sodium glutamate, citric acid, sodium benzoate, potassium sorbate, sodium saccharin…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1653-2026·2026-04-15

    Siemens ARTIS imaging systems may display an inflated patient dose reading

    Siemens ARTIS pheno and ARTIS Icono systems may sporadically display a major increase in the x-ray dose applied, although the actual dose applied remains within system settings and regulatory limits.

    Product
    ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1647-2026·2026-04-08

    Trilogy Evo O2 obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo O2 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2026·2026-04-08

    Trilogy Evo Universal obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo Universal ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1646-2026·2026-04-08

    Trilogy Evo obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2026·2026-04-08

    Magnesium sulfate pouch recalled as Class I for containing tranexamic acid

    One lot of Magnesium Sulfate in Water for Injection is being recalled after a foil pouch labeled as magnesium sulfate was found to contain an IV bag of tranexamic acid.

    Product
    MAGNESIUM SULFATE — MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0661-2026·2026-04-08

    Imu-Tek Colostrum-5 Powder Recalled Due to Under-Processing Risk

    Imu-Tek Animal Health has recalled Imu-Tek Colostrum-5 Powder because the product may be under-processed. The recalled lot was distributed across 29 states.

    Product
    Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort…
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·H-0640-2026·2026-04-08

    Spray Dried Dairy Powder recalled due to Salmonella contamination

    Lone Star Dairy Products LLC is recalling Spray Dried Dairy Powder in 25 kg bags and 1 metric ton totes due to Salmonella identification in finished product testing.

    Product
    Spray Dried Dairy Powder 25 kg bags or 1 metric ton totes
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1637-2026·2026-04-08

    Volara ventilator adapter recalled as Class I over desaturation and barotrauma

    Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.

    Product
    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1591-2026·2026-04-08

    Impella controller purge blocked alarm may be delayed on older pumps

    Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.

    Product
    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1648-2026·2026-04-08

    Trilogy EV300 obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy EV300 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1589-2026·2026-04-08

    Impella purge cassettes recalled as Class I over purge leak risk

    Purge Cassettes sold within Impella Pump Sets and individually packaged are being recalled because of an increased risk of purge leaks with Generation 1 purge cassettes.

    Product
    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1679-2026·2026-04-08

    Philips Azurion 5 M12 X-ray may not start from foot switch

    Philips is recalling the Azurion 5 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.

    Product
    Azurion 5 M12; System Code: (1)722227, (2)722231;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2026·2026-04-08

    VOLT locking screw taps swapped between lots carry incorrect thread

    The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2026·2026-04-08

    Medline ENFit G-tube connector kits may leak from dimensional defect

    Medline is recalling kits containing ENFit G-tube connectors because the connectors were not made to required dimensional specifications and may not form a proper seal.

    Product
    Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2026·2026-04-08

    Medline endoscopy kits contain recalled Olympus biopsy valves shedding fragments

    Medline is recalling BAL and ENDO kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.

    Product
    Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2026·2026-04-08

    MiniMed 620G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 620G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 620G Insulin Pump (MMT-1750)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1668-2026·2026-04-08

    Philips Allura Xper FD20/10 X-ray may not start from foot switch

    Philips is recalling the Allura Xper FD20/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.

    Product
    Allura Xper FD20/10; System Code: 722029;
    Category
    Medical Device
    Distribution
    Distributed nationwide