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.

12176–12200 of 27206

  • HighFDA (Drugs)·D-0383-2024·2024-03-20

    TRP Natural Eyes Red Eye Relief eye drops recalled for sterility concerns

    The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.

    Product
    TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2024·2024-03-20

    CVS Health Wound Dressing Recalled for Failed Sterility Testing

    Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.

    Product
    CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2024·2024-03-20

    CLEARLINK Solution Set Adapter recalled for potential drip chamber leaks

    Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.

    Product
    CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0382-2024·2024-03-20

    TRP Natural Eyes Pink Eye Relief Eye Drops Recalled for Sterility Concerns

    TRP Natural Eyes Pink Eye Relief sterile eye drops are being recalled due to lack of assurance of sterility. The recall affects 139,656 bottles distributed nationwide.

    Product
    TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2024·2024-03-20

    STERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk

    Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.

    Product
    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0378-2024·2024-03-20

    TRP Natural Eyes Dryness Relief Eye Drops Recalled for Lack of Sterility Assurance

    Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2024·2024-03-20

    Hip Prosthesis Stem Labels Lack Clear Guidance on Size and Type

    A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.

    Product
    SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0375-2024·2024-03-20

    TRP Natural Eyes Allergy Relief Eye Drops Recalled for Sterility Assurance Issues

    Optikem International is recalling TRP Natural Eyes Allergy Eyes Relief eye drops due to lack of assurance of sterility. The recall affects 30,240 bottles distributed nationwide.

    Product
    TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0372-2024·2024-03-20

    Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation

    Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.

    Product
    Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1054-2024·2024-03-20

    Coffee recalled for potential allergen contact with almonds, pecans, coconut

    House of Coffee Beans, Inc is recalling coffee products distributed in Texas, South Carolina, and North Carolina due to potential cross-contact with almonds, pecans, and coconut. Consumers with allergies to these ingredients should not consume affected products.

    Product
    Coffee 5 pound bags, 2 pound bags, 1 pound bags, 12 ounce bags, half pound bags and/or 6 ounce bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2024·2024-03-20

    D-Clip Applier Recalled for Failure to Release During Surgery

    Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.

    Product
    D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0373-2024·2024-03-20

    Pfizer Bicillin L-A Prefilled Syringes Recalled for Improper Storage

    Mckesson is recalling Bicillin L-A prefilled syringes stored outside label specifications. The FDA Class II recall affects 70 vials distributed to direct accounts in NM, AZ, and UT.

    Product
    Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1067-2024·2024-03-20

    KALO Chocolate Cake Recalled Due to Undeclared Soy Allergen

    KALO Chocolate Cake packages contain carrot cake with undeclared soy not listed on the label. Consumers with soy allergies are at risk of allergic reaction.

    Product
    KALO Chocolate Cake All Natural Gluten Free Serving size one slice (6 oz/177g) CONTAINS MILK, EGG UPC 8 53407 00418 4 Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1290-2024·2024-03-20

    CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.

    Product
    CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0385-2024·2024-03-20

    Antibiotic Injection Recalled for Failed Stability Specification

    Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.

    Product
    TOBRAMYCIN — TOBRAMYCIN (TOBRAMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2024·2024-03-20

    ADVIA Centaur Erythropoietin Assay Affected by -35% Measurement Bias

    Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.

    Product
    ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1068-2024·2024-03-20

    The Perfect Bite Co. frozen corn bites recalled due to listeria risk

    The Perfect Bite Co. is recalling Mexican Street Corn Bites due to possible Listeria monocytogenes contamination. The product was distributed in California and Washington.

    Product
    The Perfect Bite Co. Mexican Street Corn Bites 36 count Net Wt 29.9 oz (1lb 13.9oz) 847g UPC: 813341015752. Frozen product, packaged in a paper carton.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1292-2024·2024-03-20

    Shimadzu Trinias Digital Angiography System Recalled for Capacitor Defect

    Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.

    Product
    Shimadzu, Trinias, Digital Angiography System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0370-2024·2024-03-20

    Potassium Chloride Injection Recalled Due to Pinhole Container Defects

    B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2024·2024-03-20

    SPII Lubinus Hip Prosthesis Recalled Due to Carton Label Interpretation Guidance

    Waldemar Link is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck implants due to carton labeling that could be misinterpreted during surgery. Clearer guidance is being provided to prevent surgical misapplication.

    Product
    SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1060-2024·2024-03-20

    Jacksons Chicken Salad On A Croissant recalled for potential sesame cross contact

    Capitol Commissary LLC is recalling Jacksons Chicken Salad On A Croissant due to potential sesame cross contact. The product was distributed in seven western states.

    Product
    Jacksons Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983642541561.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1057-2024·2024-03-20

    CK Egg Salad Sandwich Recall for Potential Sesame Cross-Contact

    Capitol Commissary LLC recalled CK Egg Salad Sandwich due to potential sesame cross-contact. Affected units were distributed in seven western U.S. states; consumers should not eat the product.

    Product
    CK Egg Salad Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983644000097.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1280-2024·2024-03-20

    Siemens Atellica IM Erythropoietin assay recalled for calibration bias error

    Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.

    Product
    Atellica IM Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1059-2024·2024-03-20

    Ready-to-Eat Chicken Salad Sandwich Recalled for Potential Sesame Cross-Contact

    Capitol Commissary LLC is recalling CK Chicken Salad On A Croissant due to potential cross-contact with sesame. The recall affects 29 units distributed across seven Western states.

    Product
    CK Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983644100032.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1058-2024·2024-03-20

    Jacksons Egg Salad sandwiches recalled for potential sesame allergen cross contact

    Capitol Commissary LLC is recalling 1,195 units of Jacksons Egg Salad sandwiches due to potential cross contact with sesame. Consumers with sesame allergies should not consume the affected product.

    Product
    Jacksons Egg Salad, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983642540991.
    Category
    Food
    Distribution
    0 states