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.

45001–45025 of 50512

  • HighFDA (Devices)·Z-2377-2012·2012-09-19

    Capsule Neuron Docking Station Recalled for Potential Connection Loss

    Capsule Tech Inc. is recalling 12,448 Capsule Neuron Docking Stations because they may lose connection, causing data loss or power interruption to the bedside device.

    Product
    Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2012·2012-09-19

    Custom Medical Specialties Recalls CMS-2890 Needle Local Trays

    Custom Medical Specialties is recalling 16 cases of CMS-2890 Custom Needle Local Trays because the manufacturer lacked microbial testing and the product did not meet finished goods specifications.

    Product
    CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2012·2012-09-19

    GE Healthcare Recalls Optima XR220amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR220amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition

    Exactech is recalling two Novation Modular Drill Bits after they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2292-2012·2012-09-19

    Atlas Operations Recalls foru Meal Replacement for Microbial Contamination

    Atlas Operations, Inc. is recalling 425 bottles of foru Meal Replacement dietary supplement due to possible microbial contamination.

    Product
    Meal Replacement product is labeled in part: "***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Net wt. 20 oz (1 lb 4 oz) (564 g)***A well balanced blend of old-world plant nutrition.***What's in The Perfect Shake supplement? All of the…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2370-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Tibia Augments

    Omni Life Science is recalling 312 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12279·2012-09-18

    H&M Recalls Children's Water Bottles Due to Choking Hazard

    H&M is recalling about 2,900 children's water bottles sold in the U.S. because the spout can break off, posing a choking hazard.

    Product
    Children's Water Bottle
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V454000·2012-09-17

    GM Recalls 2013 Chevrolet Sonic for Turn Signal Detection Failure

    General Motors is recalling 2013 Chevrolet Sonic vehicles because the Body Control Module may fail to detect a broken turn signal lamp, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V449000·2012-09-13

    Mobility Services Recalls Ford E-Series Vans with Wheelchair Lifts

    Mobility Services is recalling 2006-2010 Ford E-150, E-250, and E-350 vans equipped with specific wheelchair lifts because roll stop latches may fail, posing a fall risk.

    Product
    MOBILITY SERVICES — MOBILITY SERVICES FORD E-150, FORD E-250, FORD E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12276·2012-09-13

    True Innovations Recalls Prestigio Office Chairs Due to Seat Plate Breakage

    True Innovations is recalling about 8,400 Prestigio office chairs because the seat plate can break, posing a fall hazard. Consumers should stop using the chairs and contact the company for a repair kit.

    Product
    Realspace Soho Prestigio High-Back Leather Chair
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2012·2012-09-12

    Trumpf Acrobat 3000 Spring Arm Recalled for Welded Seam Cracks

    Trumpf Medical Systems is recalling Acrobat 3000 spring arms for iLED operating lights because cracks can form on the welded seam at the rear joint.

    Product
    Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·12V445000·2012-09-12

    Triumph Recalls 2006-2009 Motorcycles Due to Regulator Overheating Risk

    Triumph is recalling 2006-2009 Street Triple and Daytona 675 motorcycles because the regulator/rectifier can overheat, potentially causing the bike to stall and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH DAYTONA 675, STREET TRIPLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2321-2012·2012-09-12

    AmeriWater MRO Dialysis Systems Recalled Due to Incorrect Fuse Installation

    AmeriWater Inc is recalling 80 MRO Dialysis RO+ Systems because incorrect fuses were installed, which may cause excessive heat and device failure.

    Product
    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2132-2012·2012-09-12

    Humphrey Candy Kisses Recalled for Undeclared Milk Allergen

    The Humphrey Popcorn Co is voluntarily recalling Candy Kisses because the label fails to declare milk, a major food allergen.

    Product
    Humphrey Candy Kisses, 4 oz. individually wrapped and contained in a clear plastic bag, UPC Code 81084 00002. Bags are packed 40 to a case.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2305-2012·2012-09-12

    Siemens syngo Lab Data Manager Recall for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager and Process Manager software due to a defect that may prevent the system from flagging quality control violations appropriately.

    Product
    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2124-2012·2012-09-12

    Amport Foods Recalls Pine Nuts Due to Undeclared Peanuts

    American Importing Co. is recalling specific lots of pine nuts because they may contain undeclared peanuts, posing a risk to individuals with peanut allergies.

    Product
    Nature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 72753 4. Case Label Stock No. 5640 8/3 oz Nature's Harvest, Pine Nuts Best by: 12-28-12 363x1E1, 3 00 71725 72753 5. Amport Foods Bags…
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2133-2012·2012-09-12

    Humphrey Chocolate Drizzle Popcorn Recalled for Undeclared Soy Lecithin

    The Humphrey Popcorn Co is voluntarily recalling Chocolate Drizzle Popcorn because the label fails to declare soy lecithin.

    Product
    Humphrey Chocolate Drizzle, 5 oz. in a clear plastic bag, UPC Code 8108400009. Bags are packed 12 to a case.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2322-2012·2012-09-12

    Siemens Recalls Mobilett Mira Mobile X-Ray Systems Due to Switch Defect

    Siemens is recalling 20 Mobilett Mira mobile X-ray systems because a switch may become trapped, causing the unit to move continuously.

    Product
    Siemens Mobilett Mira. Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2012·2012-09-12

    Cook Ireland Recalls Zilver Vascular Stents Due to Sizing Error

    Cook Ireland is recalling 15 Zilver 518 Vascular Self Expanding Stents because a unit was found to be the wrong size, causing it to lodge in a sheath.

    Product
    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2012·2012-09-12

    RayStation Treatment Planning Software Recalled for Dose Calculation Error

    RaySearch Laboratories AB is recalling RayStation software versions 2.5.0.144 and 2.5.1.89 due to a dose calculation normalization issue. No patient mistreatment has occurred.

    Product
    Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12V444000·2012-09-12

    NABI Recalls 2010 Transit Buses Due to Emergency Window Handle Defect

    North American Bus Industries is recalling 2010 NABI 416 and 40LFW transit buses because emergency window release handles may fail, potentially delaying passenger exit.

    Product
    NABI — NABI 416, 40LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2012·2012-09-12

    Exactech Recalls Optetrak Logic Tibial Inserts Due to Dimensional Defects

    Exactech is recalling 193 Optetrak Logic Posterior Stabilized Tibial Inserts because they were found to be out of dimensional specification.

    Product
    OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2118-2012·2012-09-12

    Bissinger's Campfire S'Mores Salt Caramels Recalled for Gluten Mislabeling

    Karl Bissinger Inc is recalling Bissinger's Campfire S'Mores Salt Caramels because the product is labeled as gluten-free but contains wheat.

    Product
    Bissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788. The firm name on the label is Bissinger's Handcrafted Chocolatier, St. Louis, MO.
    Category
    Food
    Distribution
    16 states