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.

8076–8100 of 88183

  • SevereFDA (Drugs)·D-0413-2025·2025-05-14

    Testosterone Pellet 200 mg Recalled for Glass Particle Contamination

    BSO LLC is recalling compounded testosterone pellets nationwide because glass particles were found in vials. Affected lot numbers are 20250207@1 and 20250228@1 (expiration 1/31/2026).

    Product
    TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0406-2025·2025-05-14

    Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns

    BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% eye lubricant nationwide due to cGMP deviations and lack of assurance of sterility. The recalled product was distributed in 0.5 FL OZ dropper bottles across multiple lots with various expiration dates in 2025 and 2026.

    Product
    CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2025·2025-05-14

    Galt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue

    Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.

    Product
    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2025·2025-05-14

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall

    Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.

    Product
    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0414-2025·2025-05-14

    Testosterone Pellet 200 mg Recalled for Glass Particulate Matter

    BSO LLC is recalling Testosterone Pellet 200 mg vials nationwide due to the presence of glass particles found in pellet vials. Patients should contact their healthcare provider.

    Product
    TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0755-2025·2025-05-14

    Lamb Weston frozen hashbrown patties recalled for plastic contamination

    Lamb Weston Inc is recalling approximately 3,789 cases of frozen hashbrown patties due to the presence of plastic pieces measuring 1–8 mm in the product. No illnesses have been reported.

    Product
    Item M7422, frozen foodservice Lamb Weston Hashbrown Patties LW Formed Oval 6/3.5LB bags per case. GTIN*10044979922687. Made in USA.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1722-2025·2025-05-14

    Philips Microstream Advance Neonatal-Infant CO2 Filter Line Adapter Disconnection Risk

    Philips is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related products because the adapter may be difficult or impossible to disconnect from the endotracheal tube.

    Product
    Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2025·2025-05-14

    Atalante X Powered Exoskeleton Lateral Balance Loss Recall

    WANDERCRAFT SAS is recalling the Atalante X powered exoskeleton due to a potential loss of lateral balance that could cause patients to fall. Three units have been distributed to rehabilitation facilities in Pennsylvania and New York.

    Product
    Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1731-2025·2025-05-14

    GALT Centeze Catheter recalled due to potential sterile packaging seal failure

    Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.

    Product
    GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2025·2025-05-14

    Introducer Kit-Tearaway MicroSlide Medical Device Recall

    Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.

    Product
    Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2025·2025-05-14

    Artix MT Thrombectomy Device recalled for incorrect vessel range specification

    Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) because labeling specifies an incorrect vessel range of 2.5-6 mm instead of 3-6 mm, which could increase radial force on arteries and cause vascular complications.

    Product
    Artix MT Thrombectomy Device, REF: 32-102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2025·2025-05-14

    Introducer Needle REF NDL-107-04 Sterile Packaging Recall

    Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.

    Product
    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0754-2025·2025-05-14

    Lamb Weston frozen hashbrown patties recalled for plastic contamination

    Lamb Weston Item M7414 frozen hashbrown patties are recalled because approximately 1mm to 8mm pieces of plastic were found in the product. The affected cases were distributed in Arizona, Hawaii, and internationally.

    Product
    Item M7414, frozen foodservice Lamb Weston Hashbrown Patties, frozen, LW Formed Oval 6/3.5LB bags per case. GTIN*10044979923820. Made in USA.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1729-2025·2025-05-14

    Philips Tempus Pro Patient Monitor Software Update for Operational Issues

    Remote Diagnostic Technologies Ltd. is issuing a software update for the Philips Tempus Pro Patient Monitor due to freezing, rebooting, and potential ECG measurement accuracy issues across multiple software versions.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2025·2025-05-14

    Washer Disinfector Aquadis 56 Model 56A pump seal defect recall

    Getinge Disinfection Ab is recalling Washer Disinfector Aquadis 56 (Model 56A) units due to a frequency inverter programming error that causes the circulation pump to start earlier than expected, leading to accelerated wear on the axial seal.

    Product
    Washer Disinfector Aquadis 56; Model Number: 56A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1719-2025·2025-05-14

    Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits Recalled

    One lot of Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits (Model 750830) was stored at improper temperatures in Medline warehouses. The test kits may not perform as intended due to storage outside labeled requirements.

    Product
    Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2025·2025-05-14

    Timolol Maleate Ophthalmic Solution Recalled for Defective Container

    FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% due to a defective container where the spike of the cap becomes lodged in the bottle nozzle, preventing users from accessing the solution.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1740-2025·2025-05-14

    IntelliSpace Cardiovascular Software Echo Module Data Reporting Issue

    Philips is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x because the Echo Module may generate reports with missing or incomplete information.

    Product
    IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1723-2025·2025-05-14

    Ambu aScope 5 Broncho HD Endoscope Labeling Error Recall

    Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set due to incorrect front pouch labeling that states 5.0/2.2 instead of the correct size 5.6/2.8.

    Product
    Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0412-2025·2025-05-14

    Testosterone Pellet 100 mg recalled due to glass particle contamination

    BSO LLC is recalling Testosterone Pellet 100 mg (compounded, office use only) distributed nationwide due to glass particles found in pellet vials.

    Product
    TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2025·2025-05-14

    B Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall

    Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.

    Product
    B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1734-2025·2025-05-14

    GALT Guidewire SGW-051-07 Sterile Packaging Seal Defect Recall

    Galt Medical Corporation is recalling GALT Guidewire model SGW-051-07 due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.

    Product
    GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0411-2025·2025-05-14

    Clindamycin HCl Capsule 300 mg repackaged by RemedyRePack Inc.

    RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg, due to current Good Manufacturing Practice (CGMP) deviations—the products were manufactured in a shared facility with Ezetimibe tablets.

    Product
    Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0410-2025·2025-05-14

    Homeopathic Oral Spray Temper Tamer Recalled for CGMP Deviations

    Siddha Flower Essences is voluntarily recalling Temper Tamer homeopathic oral spray due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0752-2025·2025-05-14

    Lamb Weston Hashbrown Patties recalled for plastic contamination

    Lamb Weston frozen hashbrown patties may contain pieces of plastic material measuring 1–8 mm. The affected product was distributed in Arizona, Hawaii, and several international locations.

    Product
    Item M7204, frozen foodservice Lamb Weston Hashbrown Patties, frozen, LW Formed Oval 6/3.5LB bags per case. GTIN*10044979923813. Made in USA.
    Category
    Food
    Distribution
    2 states