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.

43076–43100 of 50511

  • HighNHTSA·13V364000·2013-08-15

    Daimler Recalls 2013-2014 Saf-T-Liner Buses Due to Fuel Label Defect

    Daimler is recalling 2013-2014 Saf-T-Liner buses because a label may fall into the fuel tank, causing the engine to stall and increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EF, SAF-T-LINER HDX, SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2013·2013-08-14

    Nestle Compat Nasogastric Feeding Tubes Recalled for Sterility Concerns

    Nestle HealthCare Nutrition is recalling 37,310 Compat Nasogastric Feeding Tubes because they were delivered in insufficiently sealed pouches, compromising their sterility.

    Product
    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2013·2013-08-14

    Mitsubishi VERO Linear Accelerator Software Recall for Data Storage Error

    Mitsubishi Heavy Industries is recalling VERO Linear Accelerator Systems due to a software anomaly that may save treatment records to the wrong location.

    Product
    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2013·2013-08-14

    ASO Recalls HEB Wound Closure Adhesive Surgical Tape Strips Due to Sterility Concerns

    ASO, LLC is recalling HEB Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

    Product
    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2013·2013-08-14

    Stryker Recalls Sonopet Ultrasonic Aspirator Consoles Due to Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2013·2013-08-14

    Siemens IMMULITE Rapid TSH Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.

    Product
    IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2013·2013-08-14

    ASO Recalls Duane Reade Wound Closure Adhesive Surgical Tape Strips

    ASO, LLC is recalling Duane Reade Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the products are sterile.

    Product
    Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2013·2013-08-14

    Siemens IMMULITE TSH Assay Recalled for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant is not detected.

    Product
    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2013·2013-08-14

    Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Packaging Error

    Smith & Nephew is recalling 53 units of R3 XLPE acetabular liners because some 60 mm and 62 mm liners may be laser etched and packaged with incorrect size labels.

    Product
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1790-2013·2013-08-14

    Giant Eagle Chocolate Covered Peanuts Recalled for Undeclared Milk Allergen

    Giant Eagle is recalling Chocolate Covered Peanuts because the label fails to clearly state the presence of a milk allergen, listing only whey.

    Product
    Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1926-2013·2013-08-14

    SpineFrontier Recalls Rev E PedFuse Return Screw Inserters Due to Loose Set Screw

    SpineFrontier, Inc. is recalling eight Rev E PedFuse Return Screw Inserters because a set screw can loosen, causing the collar and locking sleeve to slide off the instrument.

    Product
    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1786-2013·2013-08-14

    Aqua Star Raw Shrimp Recalled Due to Salmonella Contamination

    Aqua Star (USA) Corp. is recalling raw frozen shrimp due to Salmonella. Consumers in NJ, MA, PA, and NY should discard the product.

    Product
    The master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. The Retail Label reads in part "*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***"
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1789-2013·2013-08-14

    Olam Tomato Processors Recalls Medium Chunky Salsa Due to Glass Fragments

    Olam Tomato Processors is recalling 12,870 cases of Home Style Select Medium Chunky Salsa because consumers reported finding large fragments of glass inside the jars.

    Product
    Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2013·2013-08-14

    ASO Recalls Premier Value Wound Closure Adhesive Tape Due to Sterility Concerns

    ASO, LLC is recalling Premier Value Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.

    Product
    Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2013·2013-08-14

    ASO Recalls Walgreens Wound Closure Adhesive Surgical Tape Strips

    ASO, LLC is recalling specific lots of Walgreens wound closure adhesive surgical tape strips because the manufacturer could not confirm the products were sterile.

    Product
    Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2013·2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recall for Corrosion Defect

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working during surgery.

    Product
    Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2013·2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recalled for Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2013·2013-08-14

    Ventana BenchMark ULTRA Staining Platform Recalled for Fluid Overflow Risk

    Ventana Medical Systems is recalling 1,735 BenchMark ULTRA automated staining platforms due to a potential waste fluid overflow that could cause electrical shorting.

    Product
    VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1788-2013·2013-08-14

    Olam Tomato Processors Recalls Mild Chunky Salsa Due to Glass Fragments

    Olam Tomato Processors is recalling Mild Chunky Salsa sold at Dollar Tree stores because consumers reported finding large fragments of glass inside the jars.

    Product
    Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2013·2013-08-14

    SpineFrontier T-Handle Strike Plate Separation Recall

    SpineFrontier, Inc. is recalling 11 T-Handles because the strike plate loosened and separated during an operation.

    Product
    T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1924-2013·2013-08-14

    Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.

    Product
    Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2013·2013-08-14

    Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection

    Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.

    Product
    Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V362000·2013-08-14

    Ice Castle RV Edition Recalled for Awning Motor Screw Shear Risk

    American Surplus is recalling 2014 Ice Castle RV Edition vehicles because awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    ICE CASTLE — ICE CASTLE RV EDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2013·2013-08-14

    Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.

    Product
    ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2013·2013-08-14

    ASO Leader Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips because the company cannot confirm the products are sterile.

    Product
    Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide