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.

17201–17225 of 27263

  • ModerateFDA (Devices)·Z-1604-2023·2023-05-24

    Dental implant system recalled for incorrect package length labeling

    Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.

    Product
    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2023·2023-05-24

    Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation

    RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.

    Product
    Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1610-2023·2023-05-24

    3M Attest Steam Chemical Integrators Recalled for Ink Leakage Risk

    3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.

    Product
    3M Attest Steam Chemical Integrators, REF 1243B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0888-2023·2023-05-24

    Wakame Seaweed Salad recalled for undeclared wheat allergen

    Origami Catering's Wakame Seaweed Salad is recalled because wheat is present but not declared in the allergen statement. Affected product: 4.5oz packages, UPC 8 51016 00235 5, distributed in Oregon and Washington.

    Product
    Wakame Seaweed Salad, ready to eat product. Net Weight: 4.5oz 127g. UPC 8 51016 00235 5. Label Ingredients declares: Seaweed (Wakame), Agar Agar ***, Sesame Seeds, Sesame Oil,***Soy Sauce ( Soy, Wheat***)*** Contains Soy, Sesame***". UPC: 8 51016 00235 5. Manufactured by Origam
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0647-2023·2023-05-24

    Vancomycin IV Injection Recalled for Lack of Sterility Assurance

    Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.

    Product
    VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1588-2023·2023-05-24

    Philips diagnostic imaging systems recalled for missing FDA certification labels

    Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

    Product
    CombiDiagnost R90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1583-2023·2023-05-24

    Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error

    Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.

    Product
    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1587-2023·2023-05-24

    Diagnostic Imaging Systems Missing FDA Certification Label

    Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.

    Product
    ProxiDiagnost N90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0837-2023·2023-05-17

    Fresh From Meijer Michigan Harvest Salad Recalled Due to Listeria Contamination

    Meijer Inc. is recalling Fresh From Meijer Michigan Harvest Salad (6.7 oz) due to Listeria monocytogenes contamination. About 2,492 units with sell-by dates from March 22-29, 2023 were distributed in six states.

    Product
    Fresh From Meijer Michigan Harvest Salad 6.7 Oz UPC - 719283679291
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0826-2023·2023-05-17

    Revolution Farms spring mix recalled for listeria contamination

    Revolution Farms Michigan Spring Mix and Farmer's Mix products distributed in Michigan, Ohio, and Wisconsin are recalled due to potential Listeria monocytogenes contamination.

    Product
    Revolution Farms Michigan Spring Mix plastic 5oz Retail container UPC 856791008004 and 3lb bulk clear poly bag UPC 856791008042 Revolution Farms Farmer's Mix 3lb bulk clear poly bag UPC 856791008134
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0825-2023·2023-05-17

    Revolution Farms Great Lakes Gourmet recalled for Listeria contamination

    Revolution Farms is recalling Great Lakes Gourmet products due to potential Listeria monocytogenes contamination. The recall affects products distributed in Michigan, Ohio, and Wisconsin.

    Product
    Revolution Farms Great Lakes Gourmet plastic 5oz Retail container UPC 856791008028 and 3lb bulk clear poly bag UPC 856791008066
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0833-2023·2023-05-17

    Meijer Avocado Chicken Bacon Ranch Salad Recalled for Listeria Risk

    Meijer is recalling Fresh From Meijer Avocado Chicken Bacon Ranch Salad due to potential Listeria monocytogenes contamination. The affected products were sold at Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.

    Product
    Fresh From Meijer Avocado Chicken Bacon Ranch Salad 8 Oz UPC - 713733246118
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1496-2023·2023-05-17

    Cordis Angioguard Emboli Capture Guidewire System Faces Separation Hazard

    Cordis's Angioguard RX/XP Emboli Capture Guidewire System is recalled due to potential separation of the delivery system and capture sheath, which could cause procedural delays, unplanned intervention, or stroke during use.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0838-2023·2023-05-17

    Fresh From Meijer Southwest Chicken Salad Recalled for Listeria Monocytogenes

    Meijer Inc. is recalling Fresh From Meijer Southwest Chicken Salad due to potential Listeria monocytogenes contamination. The product was distributed in six Midwestern states.

    Product
    Fresh From Meijer Southwest Chicken Salad 8.8 Oz UPC - 760236488323
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0839-2023·2023-05-17

    Meijer Chicken BLT Salad Recalled for Listeria Contamination

    Meijer is recalling Fresh From Meijer Chicken BLT Salad due to potential Listeria monocytogenes contamination. Affected products were distributed in six Midwestern states with sell-by dates of March 20-27, 2023.

    Product
    Fresh From Meijer Chicken BLT Salad 8.2 Oz UPC - 719283679307
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1494-2023·2023-05-17

    Emboli Capture Guidewire System recalled for component separation risk

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1493-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0840-2023·2023-05-17

    Salad Product Recalled by Meijer for Listeria Contamination

    Meijer Inc is recalling Fresh From Meijer Cranberry Spinach Shareable Salad due to potential Listeria monocytogenes contamination. The product was distributed to Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.

    Product
    Fresh From Meijer Cranberry Spinach Shareable Salad 12 Oz UPC - 708820304321
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0871-2023·2023-05-17

    Takuma Herb Salt Peanuts Recalled for Undeclared Fish Allergen

    Daiso California Warehouse is recalling Takuma food herb salt peanuts because the product contains fish (Bonito, Sardines, Tuna) but does not list it on the label. Consumers with fish allergies could unknowingly consume the product.

    Product
    Takuma food herb salt peanut 80g UPC: 4962679652767
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1427-2023·2023-05-17

    Blue Rhino G2 Tracheostomy Introducer Sets Recalled for Unsecure Connections

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets due to unsecure connections with 15mm caps and circuit components that may disconnect during medical procedures.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1488-2023·2023-05-17

    FDA Class I Guidewire System Recalled for Device Separation Risk

    Cordis US Corp is recalling the ANGIOGUARD RX / XP Emboli Capture Guidewire System because the device may separate during procedures, risking stroke or requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1485-2023·2023-05-17

    ANGIOGUARD RX/XP Guidewire System May Separate During Medical Procedures

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1495-2023·2023-05-17

    Emboli Capture Guidewire System Separation Risk Recalls ANGIOGUARD RX/XP

    Cordis US Corp is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems worldwide due to potential separation of the delivery system and capture sheath during procedures, which could cause stroke or require emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0829-2023·2023-05-17

    Revolution Farms Salad Kit Recalled for Listeria Contamination

    Revolution Farms Zesty Southwest salad kits are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Michigan, Ohio, and Wisconsin.

    Product
    Revolution Farms Zesty Southwest 6oz salad kit in plastic container UPC 856791008240
    Category
    Food
    Distribution
    3 states