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.

2376–2400 of 88106

  • SevereFDA (Devices)·Z-2160-2026·2026-06-03

    RelayPro thoracic stent-graft clasp may not release from delivery system

    The RelayPro Thoracic Stent-Graft System is subject to a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent release of the graft.

    Product
    RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2238-2026·2026-06-03

    Automated Impella Controllers recalled over alarm, power and purge cassette faults

    Automated Impella Controllers sold outside the US are being recalled over alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing and purge cassette misalignment.

    Product
    Automated Impella Controller (AIC) with the below product descriptions and 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0850-2026·2026-06-03

    Legacy Bakehouse butter parsley bagel crisps made with recalled milk powder

    Butter Parsley Bagel Crisps from Legacy Bakehouse are being recalled because they were made with recalled California Dairies milk powder over Salmonella.

    Product
    Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2231-2026·2026-06-03

    Medline anesthesia trays recalled over Huons bupivacaine quality concerns

    Medline anesthesia trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 1,100 kits are affected.

    Product
    Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2211-2026·2026-06-03

    Automated Impella Controllers await four pending hardware safety updates

    Automated Impella Controllers that have not been through Abiomed's servicing process are pending four hardware updates addressing motor control, startup and pump stop risks.

    Product
    Automated Impella Controller (AIC); Product Code: 0042-0000-US;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0856-2026·2026-06-03

    Wawa diet lemon iced tea pints recalled over undeclared milk

    Wawa Diet Iced Tea Lemon in 16 oz plastic bottles is being recalled because of an undeclared milk allergen. 616 units are affected.

    Product
    Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·H-0852-2026·2026-06-03

    Giant Eagle pita chips made with recalled California Dairies milk powder

    Giant Eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps are being recalled because they were made with recalled California Dairies milk powder over Salmonella.

    Product
    giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt 7.33 oz. Shipping Case: 12 ct - 7.33 oz Bags Net Weight: 5.49 lbs. Legacy Bakehouse, LLC, Waukesha WI 53186.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2230-2026·2026-06-03

    Halyard nitrile exam gloves failed chemical permeation performance specifications

    Halyard Purezero Ultraviolet Nitrile Exam Gloves are being recalled because they failed to meet specifications for chemical permeation performance. 452,500 units are affected.

    Product
    Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0854-2026·2026-06-03

    Fly By Jing creamy sesame noodles may contain undeclared peanut

    Fly By Jing Creamy Sesame Noodles are being recalled because possible cross-contamination resulted in an undeclared peanut allergen. 3,419 cases are affected.

    Product
    Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs. Single UPC: 8-50052-23988-6 4 pack UPC: 8-50052-23991-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2026·2026-06-03

    GE CARESCAPE v5 telemetry servers may lose patient monitoring signal

    GE HealthCare is recalling CARESCAPE Telemetry Server V5 ATO models because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.

    Product
    GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2243-2026·2026-06-03

    GE ApexPro disaster recovery USB kits may lose patient monitoring

    GE HealthCare ApexPro v5.0 Software Disaster Recovery USB Kits are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of ECG and SpO2 monitoring.

    Product
    GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2258-2026·2026-06-03

    Philips Azurion system hard drives may degrade and lose imaging

    Philips Azurion interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    Product
    Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2026·2026-06-03

    GE ApexPro v6.0 software may lose ECG and SpO2 monitoring

    GE HealthCare ApexPro v6.0 eDelivery Software is being recalled because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.

    Product
    GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2245-2026·2026-06-03

    GE CARESCAPE ARK-2250L telemetry servers may lose patient monitoring

    GE HealthCare CARESCAPE Telemetry Servers ARK-2250L are being recalled because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.

    Product
    GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2244-2026·2026-06-03

    GE CARESCAPE IOU assembly may lose ECG and SpO2 monitoring

    GE HealthCare IOU assemblies for the ARK2250 CARESCAPE Telemetry Server are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of monitoring.

    Product
    GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2246-2026·2026-06-03

    GE CARESCAPE telemetry servers may lose ECG and SpO2 monitoring

    GE HealthCare is recalling trade-in CARESCAPE Telemetry Servers because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.

    Product
    GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2259-2026·2026-06-03

    Philips Allura system hard drives may degrade and lose imaging

    Philips Allura Xper interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    Product
    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2026·2026-06-03

    Medline eye trays contain insulin syringes labeled as tuberculin syringes

    Medline EYE TRAY-LF kits are being recalled because they contain Cardinal Health syringes packaged as 1 mL tuberculin syringes but which are actually U-100 insulin syringes.

    Product
    Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2026·2026-06-03

    HydroMARK breast biopsy markers may carry the wrong inner labeling

    HydroMARK Breast Biopsy Site Markers are being recalled because boxes labeled as T3 markers may contain individual packages labeled as T4 markers. 1,910 units are affected.

    Product
    HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2240-2026·2026-06-03

    Medtronic 1x4 pocket adaptor kits carry incorrect use-by dates

    Medtronic 1x4 Pocket Adaptor Kits for Deep Brain Stimulation, model 64001, are being recalled because a limited number are labeled with incorrect use-by dates. 275 units are affected.

    Product
    Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0551-2026·2026-06-03

    Pred Mild prednisolone eye suspension failed stability specifications

    Pred Mild prednisolone acetate ophthalmic suspension 0.12% is being recalled after failing stability specifications. 2,736 bottles are affected.

    Product
    PRED MILD — PRED MILD (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2026·2026-06-03

    Medtronic 2x4 pocket adaptor kits carry incorrect use-by dates

    Medtronic 2x4 Pocket Adaptor Kits for Deep Brain Stimulation, model 64002, are being recalled because a limited number are labeled with incorrect use-by dates.

    Product
    Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0830-2026·2026-05-27

    Pork King Good seasoning made with recalled California Dairies milk powder

    Pork King Good Onion & Sour Cream Seasoning is being recalled because it was made with California Dairies milk powder recalled over Salmonella contamination.

    Product
    Pork King Good Onion & Sour Cream Seasoning. Net Wt. 3 oz (85G) bottle. UPC 8 50008-53861 2. Made by Pork King Good, Milwaukee, WI 53110.
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·H-0822-2026·2026-05-27

    Solina ranch seasoning may be contaminated with Salmonella

    Solina Ranch Seasoning in 50 lb bags is being recalled because the product has the potential to be contaminated with Salmonella. 459 bags are affected.

    Product
    Solina 6036195 Ranch Seasoning, 50lb bag
    Category
    Food
    Distribution
    7 states