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.

26576–26600 of 50462

  • HighFDA (Drugs)·D-0422-2019·2019-02-06

    BromSite Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Sun Pharmaceutical is recalling BromSite (bromfenac) 0.075% ophthalmic solution due to a lack of sterility assurance. The recall affects 69,840 bottles distributed nationwide.

    Product
    BROMSITE — BROMSITE (BROMFENAC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0780-2019·2019-02-06

    Sysco Classic Liquid Margarine Recalled for Mislabeled Soy Lecithin

    Ventura Foods LLC is recalling Sysco Classic Liquid Margarine because the interior packaging misidentifies the product as canola oil, failing to declare soy lecithin.

    Product
    Sysco Classic Liquid Margarine; 2 x 17.5 lb. plastic containers; 99961WFS
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0790-2019·2019-02-06

    XTant Medical Recalls Calix Lumbar Spinal Implants for Sterilization Concerns

    XTant Medical is recalling 632 Calix Lumbar Spinal Implant System units due to a change in packaging and sterilization method to address potential risks of compromised sterilization.

    Product
    Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0779-2019·2019-02-06

    Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk

    Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.

    Product
    Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2019·2019-02-06

    GE Healthcare Recalls LOGIQ P6 Ultrasound Scanners Due to Probe Heating

    GE Healthcare is recalling 1,897 LOGIQ P6 ultrasound scanners (Models BT07 and BT09) because the probe-head surface can reach increased temperatures during specific scans.

    Product
    GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0786-2019·2019-02-06

    Medtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects

    Medtronic is recalling 7,587 Suction and Anticoagulation Assemblies because Y-connectors may tear or crack, potentially causing leaks and blood loss.

    Product
    SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2019·2019-02-06

    Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

    Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

    Product
    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.

    Product
    Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0813-2019·2019-02-06

    Grand Strand Sandwich Company Recalls Italian Sub Sandwiches for Listeria Risk

    Grand Strand Sandwich Company is recalling 28 cases of Italian Sub Lunch Box Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed in North Carolina and South Carolina.

    Product
    LUNCH BOX SANDWICHES ITALIAN SUB; NET WT 7OZ (198G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67068 12222 8
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0791-2019·2019-02-06

    3M Surgical Clipper Recalled for Overheating Risk During Charging

    3M is recalling 19,860 Surgical Clippers due to reports of overheating when charging from modified sine wave power inverters in mobile EMS settings.

    Product
    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0778-2019·2019-02-06

    Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage

    Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls may leak during cell salvage processing.

    Product
    Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

    Product
    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19E007000·2019-02-05

    Indian Motorcycle Recalls Scout Models Due to Brake Lever Defect

    Indian Motorcycle is recalling Scout and Scout Bobber models because an accessory brake lever may apply the front brake unintentionally, increasing crash risk.

    Product
    INDIAN — INDIAN SCOUT, SCOUT BOBBER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19059·2019-02-05

    DeWALT Recalls DWD110 and DWD112 Drills Due to Shock Hazard

    DeWALT is recalling DWD110 and DWD112 drills because internal wiring can contact moving parts, posing a shock hazard. No injuries have been reported.

    Product
    DeWALT DWD110 and DWD112 drills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·011-2019·2019-02-02

    Taylor Farms Recalls Chicken Products Due To Misbranding And Undeclared Allergens

    Taylor Farms TX, Inc. is recalling approximately 2,100 pounds of chicken products incorrectly labeled as Chile Relleno due to misbranding and undeclared wheat allergens.

    Product
    Taylor Farms TX, Inc. — Taylor Farms TX, Inc. Recalls Chicken Products Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V071000·2019-02-01

    Ford Recalls 2019 Rangers for Transmission Shift Interlock Defect

    Ford is recalling 2019 Ranger vehicles with 10-speed automatic transmissions because the shift lever can move from Park without the key or brake pedal, risking unexpected movement.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V073000·2019-01-31

    Life Line Recalls 2017-2019 Ambulances Due to Brake Light Wiring Issue

    Life Line Emergency Vehicles is recalling 2017-2019 Type I and Type III ambulances because Whelen accessory brake lights may falsely illuminate, potentially confusing other drivers.

    Product
    LIFELINE — LIFELINE TYPE I, TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2019·2019-01-30

    Fetzer Medical Recalls Wrigley Obstetric Forceps Due to Functional Defect

    Fetzer Medical is recalling 10 units of Wrigley Obstetric Forceps because doctors reported being unable to pull the instruments apart.

    Product
    12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0757-2019·2019-01-30

    Fetzer De Lee Obstetric Forceps Recalled Due to Functional Defect

    Fetzer Medical is recalling 10 units of De Lee Obstetric Forceps because doctors reported being unable to pull the instruments apart.

    Product
    16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0771-2019·2019-01-30

    Varian Eclipse Treatment Planning System Proton Algorithm Recall

    Varian Medical Systems is recalling the Eclipse Treatment Planning System due to a software error in the Proton Convolution Superposition algorithm that miscalculates dose ranges for non-square CT images.

    Product
    Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2019·2019-01-30

    Stihler PRISMAFLO II Blood Return Warmer Recalled for Burn Risk

    Stihler Electronic Gmbh is recalling PRISMAFLO II blood return warmers because damage to the heating profile may cause low-level skin burns.

    Product
    Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide