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.

37601–37625 of 50506

  • HighFDA (Food)·F-3228-2015·2015-09-23

    Valley View Orchard Raspberry Rhubarb Pies Recalled for Undeclared Soy

    Valley View Orchard Pies Inc. is recalling Raspberry Rhubarb Pies due to undeclared soy lecithin. The product was distributed in Maine, New Hampshire, and Massachusetts.

    Product
    Valley View Orchard Pies, Raspberry Rhubarb
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1577-2015·2015-09-23

    Compounded Methylcobalamin Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling MIC+Methylcobalamin 4000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1481-2015·2015-09-23

    Fentanyl and Clonidine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Clonidine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2015·2015-09-23

    Intuitive Surgical Recalls Fluorescence Imaging Kits Due to Packaging Damage

    Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.

    Product
    Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2015·2015-09-23

    St Jude Merlin@home Transmitter Recalled for Backup VVI Operation

    St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.

    Product
    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2015·2015-09-23

    Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk

    Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.

    Product
    Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2015·2015-09-23

    Salter Labs NebuTech Nebulizers Recalled for Loose Inspiratory Valve Cap

    Salter Labs is recalling specific NebuTech nebulizer models because the inspiratory valve cap may detach during treatment.

    Product
    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V585000·2015-09-22

    Newmar Recalls Motorhomes Due to Exhaust Tube Fire Risk

    Newmar is recalling specific Dutch Star, Dutch Aire, and King Aire motorhomes because a flexible exhaust tube may tear, allowing hot exhaust to contact other components and increase fire risk.

    Product
    NEWMAR — NEWMAR DUTCH AIRE DP, DUTCH STAR, KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V580000·2015-09-21

    MCI Recalls 2015 Motor Coaches Due to Fire Risk in Fuse Block

    Motor Coach Industries is recalling 145 model year 2015 D4000, D4005, D4500, and D4505 vehicles because an incorrectly assembled fuse block may cause arcing and increase the risk of a fire.

    Product
    MCI — MCI D4500, D4005, D4505, D4000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V581000·2015-09-21

    Winnebago Recalls 2015-2016 Motorhomes Due to Wiring Fire Risk

    Winnebago is recalling 172 model year 2015-2016 Itasca Sunova and Winnebago Sightseer motorhomes because a wiring harness may be damaged, increasing the risk of fire.

    Product
    ITASCA — ITASCA, ITASCO, WINNEBAGO SUNOVA, SIGHTSEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V577000·2015-09-18

    Toyota Recalls RAV4 and RAV4 EV for Wiper Linkage Separation Risk

    Toyota is recalling 2009-2012 RAV4 and 2012-2014 RAV4 EV vehicles because water dripping on the wiper joint may cause corrosion and linkage separation, reducing visibility.

    Product
    TOYOTA — TOYOTA RAV4 EV, RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15246·2015-09-17

    The Land of Nod Recalls Mobiles Due to Strangulation Hazard

    The Land of Nod is recalling Follow the Herd mobiles because unraveling yarn poses an entanglement and strangulation risk to young children.

    Product
    Mobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15247·2015-09-17

    Zak Designs Recalls 26-Ounce Water Bottles Due to Choking Hazard

    Zak Designs is recalling 26-ounce water bottles sold at Target because the inner plastic straw can break, posing a choking hazard. No injuries have been reported.

    Product
    26-ounce water bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-091715·2015-09-17

    USDA Alerts on Frozen Stuffed Chicken Products Due to Salmonella Contamination

    USDA FSIS issued a public health alert for frozen, raw, stuffed chicken products from Aspen Foods due to confirmed Salmonella Enteritidis contamination.

    Product
    FSIS Issues Public Health Alert For Stuffed Chicken Products Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2752-2015·2015-09-16

    Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System

    Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.

    Product
    Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2742-2015·2015-09-16

    Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings

    Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.

    Product
    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1417-2015·2015-09-16

    3M Recalls DuraPrep Surgical Solution Due to Chemical Contamination

    3M is recalling DuraPrep Surgical Solution because the product may be contaminated with a toxic compound.

    Product
    DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled

    Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2015·2015-09-16

    Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance

    Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2015·2015-09-16

    Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System

    Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V575000·2015-09-16

    Vermeer Recalls Brush Chippers and Stump Cutters for Missing Reflectors

    Vermeer is recalling specific brush chippers and stump cutters because their LED side marker lights lack required reflectors, reducing vehicle visibility.

    Product
    VERMEER — VERMEER BC1800XL, BC1200XL, BC600XL, SC802
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers

    Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.

    Product
    Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2015·2015-09-16

    Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System

    Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.

    Product
    Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2015·2015-09-16

    Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers

    Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position during use.

    Product
    Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained…
    Category
    Medical Device
    Distribution
    Distributed nationwide