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.

30001–30025 of 50499

  • HighFDA (Devices)·Z-0474-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V096000·2018-02-07

    Audi Recalls S7 and RS7 Models for Incorrect Tire Weight Label

    Volkswagen Group of America is recalling 2014-2018 Audi S7 and RS7 vehicles because the tire information label lists an incorrect maximum weight, which could lead to vehicle overload.

    Product
    AUDI — AUDI S7, RS 7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because set screws and sleeves may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2018·2018-02-07

    FDA Recalls IASA Anchovy Extract Due to High Histamine Levels

    Manicaretti Inc is recalling IASA Colatura di Alici di Cetara anchovy extract due to high histamine levels reported by Italy.

    Product
    IASA COLATURA DI ALICI DI CETARA ANCHOVY EXTRACT; 100 ml and 250 ml sizes; UPC 100 ml - 7 93232 54200 3; UPC 250 ml - 7 93232 54203 4 Ingredients: Anchovies, Salt, Water. Product of Italy. Produced by ISA srl Pellezzano (SA)
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0454-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2018·2018-02-07

    Siemens Syngo.plaza PACS Software Recalled for Data Security and Integrity Issues

    Siemens Medical Solutions is recalling 47 units of Syngo.plaza PACS software to fix data loss, study mix-ups, and unauthorized access risks.

    Product
    Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2018·2018-02-07

    C.R. Bard Recalls Uros Automated Urine Output and Temperature Monitor

    C.R. Bard is recalling two units of the Uros Automated Urine Output and Temperature Monitor in Florida due to potential measurement inaccuracies.

    Product
    BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0434-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2018·2018-02-07

    Beaver Optimum Safety Sideport Knife Recalled Due to Retracted Shield

    Beaver-Visitec is recalling 526,220 units of Optimum Safety Sideport Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0689-2018·2018-02-07

    Mary B's Buttermilk Biscuits Recalled for Listeria Risk

    Hom'ade Foods is recalling Mary B's Buttermilk Biscuits due to potential Listeria monocytogenes contamination. Consumers should check Best If Used By dates and the letter 'M' to identify affected units.

    Product
    Mary B's Buttermilk, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Buttermilk, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ) 1247g; Mary B's Buttermilk, 30 Biscuits, Family Pack, NET WT. 60 oz (3LB 12 OZ) 1701g; Mary B's Buttermilk Biscuits, 220CT, Bulk…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0498-2018·2018-02-07

    Roche Recalls cobas e 411 Analyzers Due to Software Malfunction

    Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.

    Product
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0701-2018·2018-02-07

    Sun Noodle Tonkotsu Ramen Recalled for Undeclared Fish Allergen

    Sun Noodle New Jersey, LLC is recalling Tonkotsu Ramen because the flavor packet contains undeclared fish (sardines). Consumers with fish allergies should not eat the product.

    Product
    Sun Noodle brand Tonkotsu Ramen, Packaged in plastic clear clamshell, Banded with Tonkotsu label, distinguishable with a yellow color. (12/case); UPC 0 85315 40003 5
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0424-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide