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.

34851–34875 of 50502

  • HighFDA (Devices)·Z-2672-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 30,719 diamond coated tips and burs because labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2680-2016·2016-09-07

    Waismed Recalls NIO-P Instant Intraosseous Access Devices Due to Malfunction

    Waismed is recalling 50 units of NIO-P devices because a needle failed to release as expected during operation, posing a risk of injury.

    Product
    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2687-2016·2016-09-07

    Baxter Non-DEHP Micro-Volume Extension Set Recalled for Sterility Compromise

    Baxter Healthcare is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets because improper sealing compromised product sterility.

    Product
    Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2710-2016·2016-09-07

    BD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.

    Product
    BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2674-2016·2016-09-07

    Nakanishi Diamond Coated Dental Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 4,284 diamond coated dental tips because the packaging failed to indicate they are single-use only, posing a risk of cross-contamination.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2016·2016-09-07

    Elekta Monaco RTP System Software Recall for Contour Deletion Error

    Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.

    Product
    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Food)·F-2039-2016·2016-09-07

    Lactalis Recalls President Pub Cheese Spread for Undeclared Wheat

    Lactalis American Group is recalling President brand Pub Cheese Spread due to undeclared wheat. The product was distributed in six states.

    Product
    PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactalis American Group, Inc. Buffalo, NY 14220 --- The product is manufactured approximately every 5 weeks (from 11/02/2015 to 04/06/2016).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1995-2016·2016-09-07

    Tippin's Mini Key Lime Pie Bases Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 32 cases of Mini Key Lime Pie Bases because they were manufactured with an ingredient that may contain low levels of peanut residue.

    Product
    Tippins Mini Key Lime Base packaged in ?. UPC code is 680816000106. Packaged in 30 pie bases per case. Shipped frozen. Net wt. 11oz each.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2669-2016·2016-09-07

    Philips Recalls Allura Xper Systems Due to Power Supply Failure Risk

    Philips is recalling 1,536 Allura Xper medical imaging systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2016·2016-09-07

    Medical Vision Ab Recalls Double Pump RF Patient Cassettes

    Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes because sterile package breakage may compromise device sterility.

    Product
    Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Food)·F-1991-2016·2016-09-07

    Tippin's Key Lime Pie Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 8-inch Key Lime Pies because an ingredient may contain low levels of peanut residue.

    Product
    Tippins 8" Key Lime Pie packaged in aluminum pie plates with plastic covers. The responsible firm listed on the label is TGP, LLC Kansas City, KS 66106. UPC code is 680816050057. Packaged in 8 pies per case. Shipped frozen.
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·16V644000·2016-09-06

    Mazda Recalls Vehicles Due to Corroded Lift Gate Support Struts

    Mazda is recalling specific 2010-2016 models because lift gate support struts may corrode and break, causing the gate to drop unexpectedly and injure users.

    Product
    MAZDA — MAZDA MAZDASPEED3, MAZDA3, MAZDA5, CX-5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V642000·2016-09-06

    Audi Recalls Vehicles Due to Inoperative Side Marker Lights

    Volkswagen Group of America is recalling certain Audi models because software may cause side marker lights to fail, reducing visibility at night.

    Product
    AUDI — AUDI A4 ALLROAD, TT ROADSTER, A3 CABRIOLET, Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V638000·2016-09-02

    Tiffin Recalls 2017 Allegro Bus Motorhomes Due to Mirror Defect

    Tiffin is recalling 2017 Allegro Bus motorhomes because the passenger side mirror may move while driving, reducing visibility and increasing crash risk.

    Product
    TIFFIN — TIFFIN ALLEGRO BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16772·2016-09-02

    John Deere Recalls Backhoe Attachments Due to Crushing Hazard

    John Deere is recalling about 50 model 485A backhoe attachments because mounting hardware could loosen, causing the frame to rotate and crush the operator.

    Product
    Backhoe attachments for compact utility tractors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16256·2016-09-01

    SAHN Designs Recalls Bicycle Helmets Due to Head Injury Risk

    SAHN Designs is recalling SAHN Classic SH523 bicycle helmets because they do not meet federal impact safety standards, posing a risk of head injury.

    Product
    SAHN Classic bicycle helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·076-2016·2016-09-01

    Atherstone Foods Recalls Chicken Wraps Due to Undeclared Soy Allergen

    Atherstone Foods is recalling approximately 422 pounds of chicken wrap products because they contain soy, a known allergen, that is not declared on the label.

    Product
    Glass Onion Catering — Atherstone Foods Recalls Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2627-2016·2016-08-31

    Merge Healthcare Recalls RadSuite Software Due to Image Display Error

    Merge Healthcare is recalling RadSuite software versions 5.30 and 5.35 because the viewer may skip image slices when navigating with multiple viewports.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2647-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled for Incomplete Tip Bonding

    Bovie Medical Corporation is recalling 95 units of the BVX-330NR Bovie Precise 360 Handpiece due to potential incomplete bonding of the angled tip.

    Product
    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled Due to Adhesive Bonding Defect

    Bovie Medical Corporation is recalling 95 units of the BVX-330BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2016·2016-08-31

    Ziehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling two Ziehm Vision RFD mobile C-arms because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2644-2016·2016-08-31

    Ziehm Vision2 Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling two Ziehm Vision2 mobile C-arm devices because the radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2631-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Issues

    Medtronic is recalling three units of Alpha total knee replacement femoral components because they may not have been passivated according to job traveler requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states