The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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24651–24675 of 26084

  • HighFDA (Food)·F-0930-2021·2021-09-08

    Shrimp Tempura Kabuki Roll Recalled for Salmonella Contamination

    Mai Cuisine is recalling 12 PC Shrimp Tempura Kabuki Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp used in these products.

    Product
    12 PC Shrimp Tempura Kabuki Roll [BR] UPC: 81244803670 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0943-2021·2021-09-08

    Spicy Shrimp Inari sushi recalled for potential Salmonella contamination

    Mai Cuisine is recalling Spicy Shrimp Inari 4pc Kabuki sushi sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Spicy Shrimp Inari 4pc Kabuki [WR] UPC: 81244803408 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2385-2021·2021-09-08

    Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall

    Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.

    Product
    DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0940-2021·2021-09-08

    Shrimp Summer Roll Recall Due to Salmonella Contamination

    Mai Cuisine is recalling Shrimp Summer Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp used to make the sushi products.

    Product
    Shrimp Summer Roll UPC:81282401393 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2394-2021·2021-09-08

    CT Pin Guide Instruments Recalled for Software Imaging Alignment Error

    The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. No injuries have been reported.

    Product
    TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0958-2021·2021-09-08

    Hostess Soft White Hot Dog Buns Recalled for Listeria and Salmonella Risk

    Hostess Brands is recalling Soft White Hot Dog Buns due to positive environmental samples for Listeria and Salmonella found by the contract manufacturer. The product was distributed to retailers and distributors across 34 U.S. states.

    Product
    Hostess Soft White Hot Dog Buns, Net Wt. 12 OZ, UPC 888109110970
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-2381-2021·2021-09-08

    COVID-19 Antibody Test Kit Recalled for Failing Validation Requirements

    Thera Test Laboratories is recalling 11 EL-Anti-SARS-CoV-2 IgM test kits distributed across six states because they failed to meet FDA's updated validation requirements for accurately detecting COVID-19 antibodies.

    Product
    EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0945-2021·2021-09-08

    WOK ST SHRIMP VEGGIE LO MEIN recalled for Salmonella contamination

    Mai Cuisine is recalling WOK ST SHRIMP VEGGIE LO MEIN sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    WOK ST SHRIMP VEGGIE LO MEIN P UPC: 84003140247 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2389-2021·2021-09-08

    Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure

    Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.

    Product
    Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0936-2021·2021-09-08

    Rainbow Sushi Set recalled due to Salmonella in frozen shrimp

    Mai Cuisine's Rainbow Sushi Set sold at Whole Foods Market Genji Sushi counters in Northern California is being recalled because frozen shrimp used in the product was contaminated with Salmonella.

    Product
    Rainbow Sushi Set [WR] UPC:81244803418 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0935-2021·2021-09-08

    Ono Shrimp Poke Bowl Recalled for Salmonella Contamination

    Mai Cuisine is recalling Ono Shrimp Poke Bowl products sold at Genji Sushi counters in Whole Foods Market stores due to Salmonella contamination in frozen shrimp used in the sushi products.

    Product
    ONO SHRIMP POKE BOWL UPC:84003140699 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2409-2021·2021-09-08

    Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution

    Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.

    Product
    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0957-2021·2021-09-08

    Hostess Soft White Hamburger Buns Recalled for Listeria and Salmonella Risk

    Hostess Brands, LLC is recalling Hostess Soft White Hamburger Buns because the contract manufacturer detected positive environmental samples for Listeria and Salmonella species. The affected product was distributed to retailers and distributors across 34 states.

    Product
    Hostess Soft White Hamburger Buns, Net Wt. 12 OZ, UPC 888109110987
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-2404-2021·2021-09-08

    Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment

    Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.

    Product
    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0786-2021·2021-09-08

    Akorn Artificial Tears Ointment Recalled for Non-Sterility

    Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.

    Product
    Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0938-2021·2021-09-08

    Shrimp California Roll Recall Due to Salmonella Contamination

    Mai Cuisine is recalling Shrimp California Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Shrimp California Roll [BR] UPC: 81244803702 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2396-2021·2021-09-08

    Surgical alignment software error recalled in patient-specific orthopedic instruments

    DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.

    Product
    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2379-2021·2021-09-08

    Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure

    Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.

    Product
    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2021·2021-09-08

    Surgical arm suspension kits recalled due to sterilization concerns

    Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.

    Product
    Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0789-2021·2021-09-08

    China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination

    China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.

    Product
    CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2021·2021-09-08

    FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk

    Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.

    Product
    EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2021·2021-09-08

    MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle

    MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.

    Product
    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2021·2021-09-08

    CoolSculpting Elite System Software Error May Misreport Thermal Events

    The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.

    Product
    CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Drugs)·D-0788-2021·2021-09-08

    China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination

    China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.

    Product
    CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0937-2021·2021-09-08

    Sushi Products Recalled Due to Salmonella in Frozen Shrimp

    Mai Cuisine is recalling sushi products sold at Genji Sushi counters in Northern California Whole Foods Markets due to Salmonella contamination in frozen shrimp used as an ingredient. Products with hand-crafted dates of 8/12/2021 or 8/13/2021 are affected.

    Product
    Sept Box of The Month (NCA) WR UPC: 84003140397 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state