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.

34776–34800 of 50502

  • HighFDA (Devices)·Z-2726-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Localization Systems Due to Tip Breakage

    Hologic is recalling 535 units of SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V666000·2016-09-14

    Freightliner Trucks Recalled for Incorrect Brake Malfunction Indicator Label

    Daimler Trucks is recalling 2016-2017 Freightliner trucks because the brake malfunction light may display 'PARK' instead of 'BRAKE', potentially hiding a braking issue.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC BUSINESS CLASS M2, S2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2059-2016·2016-09-14

    Pancake Mix Recalled for Undeclared Soy Allergen in Puerto Rico

    Productos La Finca, Inc. is recalling specific lots of Mr. Special Pancakes & Waffle Mix sold in Puerto Rico due to undeclared soy lecithin.

    Product
    Product label reads in part: "MR.SPECIAL PANCAKES***PANCAKES & WAFFLE MIX***Peso Neto/Net Weight 11 gr"
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·16V663000·2016-09-14

    Smeal Recalls 2015-2016 Aerial Fire Apparatus Due to Touchscreen Defect

    Smeal is recalling 2015-2016 Aerial fire apparatus vehicles because touchscreen false activations may turn accessories on or off, increasing crash risk.

    Product
    SMEAL — SMEAL AERIAL FIRE APPARATUS, AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2097-2016·2016-09-14

    McCain Breaded Stuffed Jalapeno Poppers Recalled for E. Coli O121 Contamination

    McCain Foods USA is recalling breaded stuffed jalapeno poppers because the flour used in the product was contaminated with E. Coli O121.

    Product
    Breaded stuffed Jalapenos poppers labeled in part: Anchor breaded Fiesta Bold Poppers, breaded stuffed jalapenos, keep frozen. The product is packaged in a green 4 lb. box with white, green and orange lettering.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2016·2016-09-14

    Philips BrightView X Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2016·2016-09-14

    GE Healthcare Recalls SIGNA Creator and Explorer MRI Devices

    GE Healthcare is recalling SIGNA Creator and SIGNA Explorer MRI scanners due to an incorrect RF Power Monitor Function that could cause higher than expected thermal dose and localized heating to patients.

    Product
    GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
    Category
    Medical Device
    Distribution
    12 states
  • HighNHTSA·16V661000·2016-09-14

    Honda Recalls 2014-2015 Grom and NSS300 Motorcycles for Fuel Pump Defect

    Honda is recalling 2014-2015 Grom 125 and NSS300 motorcycles because a resin bracket in the fuel pump may swell and seize, causing the engine to stall and increasing crash risk.

    Product
    HONDA — HONDA GROM125, NSS300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2016·2016-09-14

    Siemens e.cam and Symbia E Gamma Camera Patient Bed Recall

    Siemens is recalling e.cam and Symbia E gamma camera systems because patient hair can become caught in the patient bed drive mechanism.

    Product
    e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2063-2016·2016-09-14

    Almojabanas Rice and Wheat Flour Fritter Mix Recalled for Undeclared Soy

    Productos La Finca, Inc. is recalling Almojabanas Rice and Wheat Flour Fritter Mix because it contains undeclared soy lecithin.

    Product
    Product label reads in part: "Maga***ALMOJABANAS***RICE AND WHEAT FLOUR FRITTER MIX***Peso Neto/Net Weight 6 oz (171gr)***Productos La Finca, Inc.*** Zona Industrial Machuchal***Avenida Quilinchini #61***Sabana Grande, PR 00637"
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·16V664000·2016-09-14

    Thomas Built Buses Saf-T-Liner C2 Recall for Brake Indicator Error

    Daimler Trucks is recalling 2016-2017 Thomas Built Buses Saf-T-Liner C2 school buses because the brake malfunction light may display "PARK" instead of "BRAKE," increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1483-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors

    Amerisource Health Services is recalling 1,416 cartons of 15 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2016·2016-09-14

    Invivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display

    Invivo Corporation is recalling Xper Flex Cardio Patient Monitoring Systems because SpO2 and NIBP measurements may freeze on the display.

    Product
    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2732-2016·2016-09-14

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems due to a risk of specimen misidentification when the Primary Identifier is set to Tube Position ID.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1486-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 834 cartons of amphetamine extended-release capsules because blister cavities may contain more than one tablet or capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2054-2016·2016-09-14

    Cornmeal Pancakes Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling 16 oz cornmeal pancake canisters for containing undeclared soy lecithin. The product was distributed in Puerto Rico.

    Product
    Product label reads in part: "Maga PANCAKES DE MAIZ***CORNMEAL PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2718-2016·2016-09-14

    ArjoHuntleigh Sara Combilizer Recalled for Potential Tipping Hazard

    ArjoHuntleigh is recalling 106 Sara Combilizer patient lifts due to a potential tipping hazard identified during internal testing. No adverse events or customer complaints have been reported to date.

    Product
    ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2733-2016·2016-09-14

    Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise

    Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.

    Product
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2016·2016-09-14

    Best Sanitizers Recalls Acecide-C High Level Disinfectant Due to Acid Degradation

    Best Sanitizers Inc is recalling specific lots of Acecide-C High Level Disinfectant & Sterilant because the acid solution is degrading faster than normal.

    Product
    Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2746-2016·2016-09-14

    Maquet Operating Room Table Connecting Bracket Recall for Welded Joint Failure

    Maquet is recalling Connecting Bracket (Fixture) Devices because post-market surveillance reports indicate the welded joint between the square mount and the first fixable swivel joint is broken.

    Product
    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2086-2016·2016-09-14

    Archer Farms Quinoa Recalled for Undeclared Wheat Allergen

    Superior Foods is recalling Archer Farms Quinoa 10 oz bags due to undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    Archer Farms Quinoa 10 oz packaged in flexible plastic bag
    Category
    Food
    Distribution
    7 states