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.

35551–35575 of 50504

  • HighNHTSA·16V420000·2016-06-09

    Toyota Recalls Vehicles with Incorrect Load Carrying Capacity Labels

    Southeast Toyota Distributors is recalling 2015-2016 Toyota and Scion vehicles because the load carrying capacity label may be incorrect, potentially leading to vehicle overload.

    Product
    TOYOTA — TOYOTA, SCION TUNDRA, TC, HIGHLANDER, FR-S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V415000·2016-06-09

    Audi Recalls 2007-2009 A8 and S8 Models for Sunroof Glass Defect

    Volkswagen Group of America is recalling 2007-2009 Audi A8 and S8 vehicles because the sunroof glass may not be properly secured and could detach while driving.

    Product
    AUDI — AUDI S8, A8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2016·2016-06-08

    FDA Recalls Vistec X-Ray Detectable Sponges Due to Sterility Breach

    The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.

    Product
    Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V409000·2016-06-08

    Crossroads Recalls 2016-2017 Trailers Due to Propane Fire Risk

    Crossroads is recalling 2016-2017 Hill Country and Sunset Trail trailers because opening the outside kitchen door may extinguish inside burners, allowing propane to build up and potentially cause a fire or explosion.

    Product
    CROSSROADS — CROSSROADS HILL COUNTRY, SUNSET TRAIL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2016·2016-06-08

    Orthofix Firebird NXG Spinal Fixation Set Screw Driver Recalled

    Orthofix is recalling 36 units of the Firebird NXG Spinal Fixation System Set Screw Driver because the tool may disengage from the handle during use.

    Product
    Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1868-2016·2016-06-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling specific Laparotomy Packs because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0935-2016·2016-06-08

    Baptist Health Recalls 53 Bags of Piperacillin-Tazobactam Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 53 bags of IV piperacillin-tazobactam in Arkansas due to a lack of sterility assurance.

    Product
    Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1842-2016·2016-06-08

    ConMed Recalls Hip Preservation System PreBent Burs Due to Metal Shavings

    ConMed is recalling 991 Hip Preservation System PreBent Burs because an assembly error caused metal shavings to be released during use.

    Product
    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2016·2016-06-08

    Elekta Monaco RTP System Recalled for Treatment Planning Error

    Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.

    Product
    Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2016·2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.

    Product
    SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0941-2016·2016-06-08

    Baptist Health Recalls Vancomycin Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling Vancomycin IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1871-2016·2016-06-08

    Skytron Monitor Bracket Recalled for Weld Failure Risk

    Skytron is recalling 24 Ergon III Series monitor brackets because a weld failure could cause the display to fall and injure users.

    Product
    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1870-2016·2016-06-08

    Windstone Medical Recalls General Surgery Packs with Medtronic Sponges

    Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.

    Product
    General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2016·2016-06-08

    Windstone Medical Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2016·2016-06-08

    Fujifilm ED-250XT5 Endoscope Manual Recall Due to Bacteria Reports

    Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2016·2016-06-08

    Fujifilm ED-450XT5 Endoscope Manual Correction for Infection Risk

    Fujifilm Medical Systems is correcting the ED-450XT5 endoscope manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0933-2016·2016-06-08

    Baptist Health Recalls Four Bags of Piperacillin-Tazobactam Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling four bags of Piperacillin-Tazobactam in Arkansas due to a lack of sterility assurance.

    Product
    Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1841-2016·2016-06-08

    Miltex Chisel Blade Handle Recall Due to Insecure Blade Fit

    Integra York PA, Inc. is recalling Miltex Premium Grade Self-Lock Chisel Blade Handles because a wider slot may prevent the blade from securing firmly.

    Product
    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1420-2016·2016-06-08

    Ouhlala Gourmet Recalls Raspberry Fruit Tartlets for Undeclared Milk

    Ouhlala Gourmet is recalling raspberry fruit tartlets because the finished product labeling fails to declare milk as an ingredient.

    Product
    Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g). Manufactured in France. Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2016·2016-06-08

    Siemens Dimension Vista 1500 Lab System Software Defect Recall

    Siemens is recalling Dimension Vista 1500 systems due to a software defect that may cause the device to omit a rinse step, potentially leading to discrepant patient results.

    Product
    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V410000·2016-06-08

    Oshkosh Recalls 2016 S-Series Concrete Mixers Due to Engine Stall Risk

    Oshkosh is recalling 2016 S-Series Front Discharge Concrete Mixers because a faulty engine control module may cause an unexpected engine stall, increasing crash risk.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2016·2016-06-08

    Sterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect

    Sterilmed is recalling 11,326 reprocessed Microline Scissor Tips due to a potential manufacturing defect that could result in patient injury.

    Product
    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Drugs)·D-0923-2016·2016-06-08

    Baptist Health Recalls Deferoxamine Cassettes Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling three Deferoxamine cassettes in Arkansas due to a lack of sterility assurance.

    Product
    Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state