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.

44226–44250 of 50511

  • HighFDA (Food)·F-0858-2013·2013-01-09

    Nature's Path Recalls Granola Due to Undeclared Almond Allergen

    Nature's Path Foods is recalling 25 lb. containers of Hemp Plus Granola because the product contains almonds that are not declared on the label.

    Product
    Hemp Plus Granola. The product is packaged in a 25 lb. container. The UPC is 0 58449 88001 1. The product is labeled in parts: "***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0629-2013·2013-01-09

    Stryker Medical Surgical Beds Recalled for Brake Ring Defect

    Stryker is recalling Model 3002S3EX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

    Product
    Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-124-2013·2013-01-09

    New England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns

    New England Compounding Center is recalling specific Triamcinolone vials nationwide because the company cannot guarantee the products are sterile.

    Product
    Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0860-2013·2013-01-09

    Nature's Plus Spiru-tein Energy Meal Recalled for Gluten Mislabeling

    Natural Organics is recalling Nature's Plus Spiru-tein High Protein Energy Meal, S'mores flavor, because it is labeled gluten-free but contains gluten.

    Product
    Nature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052. There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2013·2013-01-09

    Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer

    Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.

    Product
    PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2013·2013-01-09

    Mindray DPM Central Station Recalled for Patient Data Anomaly

    Mindray is recalling two DPM Central Station units due to a software anomaly that may replace one patient's trend data with another's.

    Product
    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2013·2013-01-09

    Medtronic Intersept Custom Tubing Packs Recalled for Packaging Damage

    Medtronic is recalling Intersept Custom Tubing Packs because packaging trays may be damaged, compromising product sterility.

    Product
    Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2013·2013-01-09

    Maquet Yuno Extension Table Device Recalled for Screw Tension Issue

    Maquet Inc. is recalling 63 Yuno Extension Table Devices due to a potential issue with the screw tension of the extension device.

    Product
    Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0632-2013·2013-01-09

    Horiba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent

    Horiba Medical is recalling ABX PENTRA AST CP reagent because it recorded incorrect low values for high AST levels without triggering an alarm.

    Product
    ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2013·2013-01-09

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 180 Plum A+ Hyperbaric Infusion Pumps because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of medication.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-123-2013·2013-01-09

    Saline 10% and 3% vials are recalled for sterility assurance concern

    New England Compounding Center is recalling 54 vials of Saline 10% and 3% in 5 mL and 10 mL sizes because sterility could not be assured. The vials were distributed nationwide, and all lot codes are included.

    Product
    Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·13088·2013-01-08

    HEICO Neon Sign Power Supply Transformers Recalled Due To Fire Hazard

    HEICO lighting is recalling specific neon sign power supply transformers because they do not meet UL standards and pose a fire risk. No injuries have been reported.

    Product
    Power Supply Transformers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13087·2013-01-08

    Fisher-Price Recalls Rock 'n Play Infant Sleepers Due to Mold Risk

    Fisher-Price is recalling about 800,000 Rock 'n Play infant sleepers because mold can develop between the cushion and frame, posing a respiratory risk to infants.

    Product
    Newborn Rock 'n Play Sleeper™
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13715·2013-01-04

    Amana Heating and Cooling Units Recalled for Fire Hazard

    Goodman Company is recalling Amana packaged heating and cooling units because inaccurate serial plates could lead to undersized wiring and fire.

    Product
    Amana Packaged Gas/Electric Heating and Cooling units
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2013·2013-01-02

    Roche COBAS AmpliPrep Instruments Recalled Due to Disabled Clot Detection Feature

    Roche is recalling 7 COBAS AmpliPrep instruments because the sample clot detection feature was disabled during quality control, potentially allowing unflagged clotted samples to be processed.

    Product
    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-102-2013·2013-01-02

    Lloyd Inc. Recalls Subpotent Thyro-Tab 0.075 mg. Tablets

    Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab 0.075 mg. tablets due to subpotency and stability issues.

    Product
    Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2013·2013-01-02

    Beckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects

    Beckman Coulter is recalling Access Immunoassay Systems because pulley drive components may break or disconnect, causing inadequate washing or mixing.

    Product
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2013·2013-01-02

    Brookstone Recalls Heated Body Beans Due to Burn Risk

    Brookstone is recalling 109,956 electrically heated body bean products nationwide due to a risk of skin burns.

    Product
    Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2013·2013-01-02

    Stryker T2 Humerus System Teflon Tube Recalled Due to Material Embrittlement

    Stryker Howmedica Osteonics is recalling 100 units of the T2 Humerus System Teflon Tube because a manufacturing error caused the tube material to become embrittled.

    Product
    Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2013·2013-01-02

    Greatbatch Medical Recalls MobiCath Bi-Directional Guiding Sheaths Due to Liner Anomalies

    Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths because visual inspections found loose or frayed liner material inside the device.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the…
    Category
    Medical Device
    Distribution
    40 states
  • HighCPSC·13084·2012-12-27

    Meijer Recalls Falls Creek Kids Denim Jeans Due to Choking Hazard

    Meijer is recalling Falls Creek Kids infant and toddler denim jeans because a snap may detach, posing a choking hazard to young children.

    Product
    Falls Creek Kids infant and toddler denim jeans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide