The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

19326–19350 of 50410

  • HighNHTSA·21V698000·2021-09-09

    2021 RAM 1500 recalled for incorrect spare tire installation

    Chrysler is recalling 2021 RAM 1500 vehicles with an incorrect-size spare tire that does not match the placard specifications. Improper tire inflation could increase the risk of crashes.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21781·2021-09-09

    Vitus 14 and Vitus 16 Kids Bikes Recalled for Crash Hazard

    Wiggle Ltd. is recalling approximately 280 Vitus 14 and Vitus 16 kids bikes because they lack required footbrakes and may present a risk of injury to young children who cannot stop using handbrakes alone.

    Product
    VITUS 14 and VITUS 16 Kids Bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V699000·2021-09-09

    2021 RAM ProMaster City Seat Belt Retractors May Fail to Secure Child Restraints

    Chrysler is recalling 2021 RAM ProMaster City and ProMaster vehicles because seat belt retractors may deactivate early, preventing child restraints from securing properly. This can increase injury risk during crashes.

    Product
    RAM — RAM PROMASTER, PROMASTER CITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V700000·2021-09-09

    Newmar Recreational Vehicles: Instrument Cluster May Go Blank While Driving

    Newmar is recalling certain 2019-2021 recreational vehicles because the instrument cluster may intermittently go blank while driving, potentially hiding critical information like vehicle speed and warning lights.

    Product
    NEWMAR — NEWMAR KING AIRE, MOUNTAIN AIRE, LONDON AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2021·2021-09-08

    DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error

    DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT 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-2395-2021·2021-09-08

    Surgical instrument software error may cause limb misalignment

    DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.

    Product
    TRUMATCH CT PIN GUIDE KIT 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-2410-2021·2021-09-08

    COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories

    COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.

    Product
    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0952-2021·2021-09-08

    BR Special Roll Super Set Sushi Recalled for Salmonella Risk

    Mai Cuisine is recalling BR Special Roll Super Set 16-piece sushi products sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the product.

    Product
    BR SPECIAL ROLL SUPER SET 16PCL UPC:81282401203 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0933-2021·2021-09-08

    Genji Sushi Products Recalled for Salmonella Contamination

    Mai Cuisine is recalling approximately 1490 packages of August Box of the Month sushi products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination from frozen shrimp used in the products.

    Product
    August Box of the Month NCA UPC: 84003140261 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0904-2021·2021-09-08

    Your Way Fresh Yogurt Parfait Recalled for Undeclared Soy

    Your Way Fresh Sliced Banana + Strawberry Yogurt Parfait is being recalled because the yogurt ingredient contains soy lecithin, but soy is not declared on the product label. Consumers with soy allergies may face serious health risks.

    Product
    Your Way Fresh, Sliced Banana + Strawberry Yogurt Parfait; Net wt. 6.25 oz (177 g); UPC 8 54426 00807 8; Distributed by Your Way Fresh, Newport Beach, CA, 12 cups per case;
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0934-2021·2021-09-08

    Double Shrimp BBQ Roll recalled due to Salmonella contamination

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

    Product
    Double Shrimp BBQ Roll WR UPC: 81244803204 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0944-2021·2021-09-08

    Spicy Shrimp Tempura Roll Recalled for Salmonella Contamination

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

    Product
    Spicy Shrimp Tempura Roll [WR] UPC: 81244803443 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0946-2021·2021-09-08

    Wok st. Shrimp Lo Mein Recalled for Salmonella Contamination

    Mai Cuisine is recalling Wok st. Shrimp Lo Mein (UPC 84003140405) 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 Lo Mein UPC: 84003140405 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1016-2021·2021-09-08

    Rocky Top Farms Cherry Butter recalled for undeclared milk allergen

    Rocky Top Farms Cherry Butter is being recalled because it contains undeclared milk, which can pose a serious risk to consumers with milk allergies. The recall affects retail and food service packages.

    Product
    Rocky Top Farms Cherry Butter sold in 1 gallon food service and 10oz retail sizes. 10 oz retail units may be sold individually and as multi-pack and variety packs online.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0776-2021·2021-09-08

    Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination

    Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg (4,992 bottles, batch 1408824A, expiration 08/2023) distributed nationwide due to out-of-specification microbial test results in an excipient ingredient.

    Product
    Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2021·2021-09-08

    Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure

    Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.

    Product
    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2021·2021-09-08

    Medical Imaging Software Bug May Cause Incorrect X-ray Exposure

    Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.

    Product
    CombiDiagnost R90 Software Version R1.0 and R1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0948-2021·2021-09-08

    Mai Cuisine Spicy Shrimp Tempura Roll Recalled for Salmonella

    Mai Cuisine is recalling Spicy Shrimp Tempura Roll sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    SPICY SHRIMP TEMPURA ROLL UPC: 81282401109 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • 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 (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…
    Category
    Medical Device
    Distribution
    10 states
  • 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-0941-2021·2021-09-08

    Spicy Shrimp California Roll Recalled for Salmonella Contamination

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

    Product
    Spicy Shrimp California Roll [WR] UPC: 81244803444 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 (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 (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