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.

41176–41200 of 50511

  • HighFDA (Devices)·Z-1635-2014·2014-05-28

    Microline Renew Fenestrated Control Tip Grasper Recalled for Jaw Breakage

    Microline Surgical is recalling 540 units of Renew Fenestrated Control Tip Graspers because the jaw may break when force is applied.

    Product
    Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1650-2014·2014-05-28

    Smiths Medical Recalls Snuggle Warm Sterile Cardiac Warming Blankets

    Smiths Medical ASD, Inc. is recalling 2,120 Snuggle Warm Sterile Cardiac Connective Warming Blankets because the hose could separate from the blanket.

    Product
    SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1627-2014·2014-05-28

    Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect

    Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.

    Product
    LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2014·2014-05-28

    Siemens Recalls Dimension Vista Cyclosporine Test Kits Due to Under-Recovery

    Siemens Healthcare Diagnostics is recalling Dimension Vista CSA and CSAE test kits because they may under-recover cyclosporine levels when using Small Sample Containers.

    Product
    Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1950-2014·2014-05-28

    Aqua Filter Fresh Recalls Purified Water Bottles Due to Bacteria

    Aqua Filter Fresh, Inc. is recalling 2,436 bottles of purified water distributed in Pennsylvania and West Virginia after lab tests detected coliforms and E. coli.

    Product
    On cap Purified Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Permit #504 Source: Plum Boro Municipal Authority 15239 Processed by Reverse Osmosis, Steam Distillation, Micro-filtration, Ozonation, UV *Minerals added for taste On Bottle side: Tyler…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1651-2014·2014-05-28

    Heraeus Kulzer Recalls Gluma Desensitizer Power Gel Due to Extrusion Risk

    Heraeus Kulzer is recalling Gluma Desensitizer Power Gel because it may extrude all at once, causing irritation, burning, or blistering to patients or dental professionals.

    Product
    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1951-2014·2014-05-28

    Whole Foods Recalls Bolivian Artichoke Salad Due to Glass Contamination

    Whole Foods Market Group Inc. is recalling 190 lbs of Bolivian Artichoke Salad sold in 10 lb bulk bags due to potential glass contamination.

    Product
    Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1649-2014·2014-05-28

    Medline Esmark Elastic Bandages Recalled for Sterilization Failure

    Medline Industries is recalling 2,860 Esmark Elastic Bandages because they may not have been properly sterilized.

    Product
    Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14193·2014-05-28

    Hamilton Beach Recalls Baby Food Makers Due to Small Parts Hazard

    Hamilton Beach is recalling bébé brand baby food makers because a stainless steel pin can loosen and fall into food. No injuries have been reported.

    Product
    Baby food processor
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V279000·2014-05-27

    Ford E-150 wheelchair lift latch defect recall

    Mobility Specialists is recalling 2007-2008 Ford E-150 vans with wheelchair lifts where latches may fail, risking occupant falls.

    Product
    FORD — FORD E-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V274000·2014-05-22

    Toyota Recalls 2014 Highlanders Due to Second Row Seat Locking Defect

    Toyota is recalling 231 model year 2014 Highlanders because the second row right-hand seat may not fully lock into the track, increasing injury risk in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14189·2014-05-22

    Lakeshore Bristle Builders for Toddlers Recalled Due to Choking Hazard

    Lakeshore Learning Materials is recalling Bristle Builders for Toddlers play sets because animal figure bases can detach, posing a choking hazard to young children.

    Product
    Lakeshore Bristle Builders® for Toddlers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V272000·2014-05-22

    Toyota Recalls 2014 Highlanders Due to Air Bag Software Error

    Toyota is recalling 2014 Highlander and Highlander Hybrid vehicles because improper air bag software may fail to properly restrain larger front passengers in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER HYBRID, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2014·2014-05-21

    Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure

    Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.

    Product
    Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1612-2014·2014-05-21

    Medline Mucus Specimen Traps Recalled for Potential Sterility Issues

    Medline Industries is recalling 1,610 mucus specimen traps because they may not be sterile, which could contaminate patient specimens.

    Product
    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2014·2014-05-21

    SCC Soft Computer Recalls SoftMic Laboratory Information System Software

    SCC Soft Computer is recalling SoftMic version 4.0.7.0 because missing SNOMED codes may cause incomplete patient data and delayed treatment updates.

    Product
    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1616-2014·2014-05-21

    Roche Recalls ACCU-CHEK Compact Plus Test Strips Due to Ceftriaxone Interference

    Roche is recalling ACCU-CHEK Compact Plus test strips because they may produce erroneously low blood glucose readings in patients taking Ceftriaxone.

    Product
    ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.

    Product
    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1608-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1606-2014·2014-05-21

    Zimmer Recalls Neoprene Tennis Elbow Supports Due to Latex Contamination

    Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.

    Product
    Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2014·2014-05-21

    Biomet ExploR Radial Stem Recalled for Missing Threads

    Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.

    Product
    ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2014·2014-05-21

    Zimmer Hinged Knee Support Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 546 units of Hinged Knee Supports because raw material labeled as latex-free actually contained latex.

    Product
    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14187·2014-05-21

    Nest Labs Recalls Nest Protect Smoke and Carbon Monoxide Alarms

    Nest Labs is recalling Nest Protect Smoke + CO alarms because the Nest Wave feature can prevent the alarm from sounding during a fire. No injuries or property damage have been reported.

    Product
    Nest Protect: Smoke + CO Alarm
    Category
    Consumer Product
    Distribution
    Distributed nationwide