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.

20651–20675 of 50413

  • HighFDA (Devices)·Z-1401-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch Risk

    Siemens is recalling 1,452 ADVIA 2120i Dual Aspirate Autosamplers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2021·2021-04-21

    FDA Recalls 222 Units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads

    FDA is recalling 222 units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads due to a potential packaging defect that could compromise sterility and increase infection risk.

    Product
    Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1402-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens is recalling 33 ADVIA 2120i automated hematology analyzers because a potential sample identification mismatch may occur with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 969 ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 27 ADVIA 2120i hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2021·2021-04-21

    Sunstar Butler Clear Dip Recalled for Burkholderia Contamination

    Sunstar Americas is recalling 19,471 bottles of Butler Clear Dip due to potential contamination with Burkholderia contaminans.

    Product
    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0425-2021·2021-04-21

    Starwest Botanicals Wood Betony Herb Recalled for E. coli Presence

    Starwest Botanicals is recalling specific lots of Wood Betony Herb due to the presence of E. coli species.

    Product
    Starwest Botanicals Item#: 209617-34, Item# 209617-31 Wood Betony Herb C/S Organic Stackys Officinalis Origin: Croatia Daily serving size: Pour 8-12 oz of boiling water (212F) over 1 tsp. of tea. Steep 3-4 minutes. Net. weight: 4 oz. (113.4g) Lot#: P92769, Net weight: 1…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2021·2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120 automated hematology analyzers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V269000·2021-04-20

    Manac Recalls 2018-2019 Trailers Due to Potential Steering Arm Detachment

    Manac is recalling 2018-2019 Steel Platforms, Transfer Trailers, and Square Dump Trailers because steer arm bolts may break, allowing the arm to detach and drag.

    Product
    MANAC — MANAC STEEL PLATFORM, SQUARE DUMP TRAILER, TRANSFER TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E028000·2021-04-16

    Meritor Recalls 14Xe ePowertrains Due to Electrical System Defect

    Meritor is recalling specific 14Xe ePowertrains because insufficiently crimped stator wires may cause overheating and loss of motive power, increasing crash risk.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V267000·2021-04-16

    Pioneer Recalls Prevost H3 and X3 Buses for Fire Risk

    Pioneer Coach Interiors is recalling 2019-2020 Prevost H3 and X3 vehicles because a damaged circuit board increases the risk of a fire.

    Product
    PREVOST — PREVOST H3, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V263000·2021-04-15

    Subaru Recalls Crosstrek and Forester for Rear Stabilizer Bolt Defect

    Subaru is recalling 2018-2019 Crosstrek and 2019 Forester vehicles because rear stabilizer bracket bolts may loosen and detach, increasing crash risk.

    Product
    SUBARU — SUBARU CROSSTREK, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V265000·2021-04-15

    2021 Tiffin Phaeton Motorhomes: Roof Panel Detachment Hazard

    Tiffin is recalling certain 2021 Phaeton motorhomes with roof-mounted awnings. A roof mounted body panel may be improperly attached and could detach, becoming a road hazard and increasing crash risk.

    Product
    TIFFIN — TIFFIN PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V264000·2021-04-15

    Subaru Recalls Impreza and Crosstrek for Ignition Coil Short Circuit Risk

    Subaru is recalling 2017-2019 Impreza and 2018-2019 Crosstrek vehicles because the engine control module may keep the ignition coil powered after shutdown, causing a short circuit and potential stall.

    Product
    SUBARU — SUBARU CROSSTREK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2021·2021-04-14

    Becton Dickinson Recalls Martin-Lewis Agar Due to Fungal Growth

    Becton Dickinson is recalling Martin-Lewis Agar plates because they show heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2021·2021-04-14

    Arrow OnControl Bone Lesion Biopsy System Recalled for Insertion Defect

    Arrow International is recalling OnControl Bone Lesion Biopsy Systems because the ejector rod may not insert properly, preventing sample collection.

    Product
    Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21111·2021-04-14

    Target Recalls Cat & Jack Baby Rompers Due to Choking Hazard

    Target is recalling Cat & Jack Baby Heart Ears Rompers because heart-shaped graphics on the knees can detach, posing a choking hazard to children.

    Product
    Cat & Jack Baby Heart Ears Rompers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2021·2021-04-14

    Quaker Rice Crisps Recalled for Undeclared Soy Allergen

    The Quaker Oats Company is recalling Quaker Rice Crisps Sweet Barbecue Flavor due to undeclared soy. The recall covers 4,550 bags distributed to 21 states.

    Product
    Quaker Rice Crisps Sweet Barbecue Flavor, 3.03 oz. bag, UPC 0 30000 31984 0
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0389-2021·2021-04-14

    Trident Seafoods Pacific Salmon Burgers Recalled for Metal Fragment

    Trident Seafoods is recalling frozen Pacific Salmon Burgers sold at Costco due to a metal fragment found in the product.

    Product
    Trident Seafoods Pacific Salmon Burgers (# 414469), frozen. Costco item #502497. Each retail bag contains of 12/4oz. pieces. Retail bag net wt. 48 oz (3 lb or 1.36 kg). Retail bag UPC 0 28029 14469 7. Each Master case contains of 12/3 lbs. packages. The MASTER CASE label is…
    Category
    Food
    Distribution
    3 states
  • HighCPSC·21112·2021-04-14

    Playgro Recalls Clip Clop Infant Activity Rattles Due to Choking Hazard

    Playgro is recalling Clip Clop infant activity rattle toys because the abacus ring can dislodge and release small beads, posing a choking hazard to small children.

    Product
    Clip Clop Infant Activity Rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2021·2021-04-14

    Sharp Medical Reactor and Sleeve Recalled for Sterile Barrier Defects

    Sharp Medical Products is recalling 129 units of Reactor and Sleeve REF 100-36-01 due to holes, punctures, or deep creases in the sterile barrier.

    Product
    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1379-2021·2021-04-14

    Howmedica Recalls Specialty Triathlon TS Trial Cutting Guides Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling Specialty Triathlon TS Trial Cutting Guides because the posterior condyle may fracture during transport or surgery.

    Product
    Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set…
    Category
    Medical Device
    Distribution
    7 states