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.

43126–43150 of 50511

  • HighFDA (Food)·F-1758-2013·2013-08-07

    Fisher's Homestyle Salads Recalls Crab and Shrimp Salad Due to Allergen Mislabeling

    Fisher's Homestyle Salads is recalling Crab & Shrimp Salad because the product contains undeclared allergens, including corn, wheat, and specific fish species.

    Product
    Fisher's Homestyle Salads LLC***Crab & Shrimp Salad*** packaged in 5 lb and 10 lb plastic containers.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1817-2013·2013-08-07

    Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk

    Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.

    Product
    ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1832-2013·2013-08-07

    Exactech Articulated Driver Recalled for Potential Disassembly During Use

    Exactech, Inc. is recalling 57 Articulated Driver units because the cross pin may shift out of position, potentially leading to instrument disassembly during orthopedic surgery.

    Product
    Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1818-2013·2013-08-07

    Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk

    Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.

    Product
    ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1836-2013·2013-08-07

    St. Jude Medical Recalls Eon Mini Implantable Pulse Generators

    St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.

    Product
    Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13746·2013-08-07

    LSI Recalls Wind Speed Sensors Due to Risk of Injury from Impact

    Load Systems International is recalling LSI model GS025 wind speed sensors because they may fail to display accurate data, posing a risk of injury from impact.

    Product
    LSI Wind Speed Sensors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2013·2013-08-07

    Heartware HVAD Pump Implant Kit Recalled for Electrostatic Discharge Risk

    HeartWare Inc is recalling HVAD Pump Implant Kits due to a potential electrostatic discharge (ESD) hazard. The recall covers 76 units in the US and 82 internationally.

    Product
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1869-2013·2013-08-07

    SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments

    SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.

    Product
    Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of…
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·13V308000·2013-08-07

    Navistar Recalls IC Bus Models for Inadequate Knee Protection

    Navistar is recalling certain 2011-2014 IC Bus models because seat padding failed to meet federal safety standards for knee impact protection.

    Product
    IC BUS — IC BUS CASB, ICCB, RECB, RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13257·2013-08-06

    Gerber Recalls Uppercut Fixed Blade Knife and Sheath Sets

    Gerber is recalling Uppercut Fixed Blade Knife and Sheath Sets because the sheath does not hold the knife securely, posing a laceration hazard.

    Product
    Gerber® Uppercut™ Fixed Blade Knife and Sheath Set
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13258·2013-08-06

    Glideaway Recalls Pink Sleepharmony Youth Beds for Lead Paint Violation

    Glideaway is recalling pink Sleepharmony metal youth beds because the surface paint contains lead levels that exceed legal limits. No injuries have been reported.

    Product
    Sleepharmony Metal Youth Beds in pink
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V341000·2013-08-05

    Jaguar Recalls 2013 XF Models Due to Loose Charge Air Cooler Hose Clamp

    Jaguar is recalling 2013 XF 2.0L GTDi vehicles because a loose hose clamp may allow the Charge Air Cooler hose to detach, potentially causing the engine to stall and increasing crash risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E042000·2013-08-02

    Sportworks Recalls Apex 3 Bicycle Racks Due to Latch Cracks

    Sportworks is recalling Apex 3 bicycle racks for transit buses because cracks may cause the latch to separate, creating a road hazard.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V334000·2013-08-01

    Triple E Recalls 2013 Regency GT Motorhomes Due to Awning Motor Defect

    Triple E is recalling 2013 Regency GT motorhomes because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    REGENCY GT — REGENCY GT GT27S, GT29T, GT24MB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13255·2013-07-31

    Leisure Ways Kids' Outdoor Furniture Recalled for Lead Paint Violation

    Far East Brokers is recalling about 14,000 Leisure Ways kids' outdoor furniture items because the red paint contains excessive lead, violating federal standards.

    Product
    Leisure Ways® Brands Kids Outdoor Furniture
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-821-2013·2013-07-31

    Gilead Recalls AmBisome Injection Due to Potential Sterility Assurance Issues

    Gilead Sciences is recalling 478,352 vials of AmBisome (amphotericin B) liposome for Injection due to a lack of sterility assurance detected during routine manufacturing simulations.

    Product
    AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1811-2013·2013-07-31

    Church & Dwight Recalls Contaminated Sodium Bicarbonate for Medical Use

    Church & Dwight is recalling specific lots of Sodium Bicarbonate, USP, used in medical devices and drugs due to metal and other contamination.

    Product
    Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1747-2013·2013-07-31

    Jacqueline's Almond Burst Cookies Recalled for Undeclared Milk Allergen

    Price Chopper is recalling Jacqueline's Almond Burst Cookies because they contain an undeclared milk allergen. Consumers should not eat the product.

    Product
    Jacqueline's GOURMET COOKIES Almond Bursts COOKIES, Net Wt. 11 oz (8 units total) packed in clear plastic with white labeling----Shelf life is 12 months frozen and 7 days after baked.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1775-2013·2013-07-31

    Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues

    Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers because potential clip formation and feeding issues may cause vessel damage or insufficient occlusion.

    Product
    LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument…
    Category
    Medical Device
    Distribution
    Distributed nationwide