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.

27976–28000 of 50462

  • HighFDA (Devices)·Z-2805-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2823-2018·2018-08-22

    Merit Medical Recalls Pediatric Peritoneal Dialysis Catheters Due to Mix-Up

    Merit Medical Systems is recalling specific lots of Flex-Neck Classic Peritoneal Dialysis Catheters (Pediatric) due to a mix-up with adult catheters.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V537000·2018-08-20

    Volkswagen Recalls 2018 Atlas Vehicles Due to Air Bag Control Module Risk

    Volkswagen is recalling 2018 Atlas vehicles because a twisted air conditioning drain tube may allow water to enter the air bag control module, potentially causing unintentional air bag deployment.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E085000·2018-08-20

    Allison Transmission Recall for Potential Loss of Drive

    Allison is recalling certain H 50 and H 40 Drive Units because pressure switches may fail, causing a loss of drive and increasing crash risk.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18760·2018-08-17

    Polaris Recalls ACE 150 and Ranger 150 Vehicles Due to Crash Hazard

    Polaris is recalling about 5,900 ACE 150 and Ranger 150 recreational off-highway vehicles because the front suspension lower ball joint can separate, posing a crash hazard.

    Product
    Model year 2017-2018 Polaris ACE 150 and model year 2018 Polaris Ranger 150 recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2018·2018-08-15

    Stryker rHead Radial Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 211 Stryker rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 285 rHead Stem Implant Plasma Coated, Size 2 units because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1791-2018·2018-08-15

    Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella Risk

    Pepperidge Farm is recalling specific Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.

    Product
    Pepperidge Farm Goldfish Baked Snack Crackers Flavor Blasted Slammin Sour Cream & Onion. Net Wt. 6.6 oz. (187g) bag, UPC 14100-09480.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1818-2018·2018-08-15

    Flowers Foods Recalls Captain John Derst's Bread Due to Salmonella Risk

    Flowers Foods is recalling Captain John Derst's Good Old Fashioned Bread due to potential salmonella contamination in a whey powder sub-ingredient.

    Product
    Captain John Derst's Good Old Fashioned Bread***NET WT 20 OZ (1 LB 4 OZ) 567 g***Nutrition Facts 22 servings per container*** Calories 80***INGREDIENTS:UPC 071316001180***INGREDIENTS: ENRICHED FLOUR, MALTED BARLEY, FLOUR, NIACIN, REDUCED IRON*** DISTRIBUTED BY FLOWERS BAKERIES…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2018·2018-08-15

    Natus Neurology Recalls ErgoJust Video Carts Due to Pole Failure Risk

    Natus Neurology is recalling 797 ErgoJust mobile video carts because a manufacturing defect may cause the video pole to fail.

    Product
    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2666-2018·2018-08-15

    Stryker Radial Stem Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics is recalling 280 Stryker rHead Radial Stem Implants because literature reviews show higher revision rates than similar devices.

    Product
    Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1817-2018·2018-08-15

    Flowers Foods Recalls Swiss Rolls Due to Potential Salmonella

    Flowers Foods is recalling Swiss Rolls snack cakes sold under multiple brands due to potential salmonella contamination in a whey powder ingredient.

    Product
    Swiss Rolls***Brand Name**Swiss Rolls Chocolate (Snack) Cakes, NET WT OZ (g) PKGS***TWIN PACKS***Nutrition Facts***Ingredients: SUGAR, WHEY (MILK), ENRICHED BLEACHED FLOUR***DISTRIBUTED BY***UPC Sold under the brand names... Mrs. Freshley's - NET WT 12 OZ (340g) 6-2 OZ…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 544 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2713-2018·2018-08-15

    Howmedica Recalls 546 Bipolar Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 546 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1793-2018·2018-08-15

    Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella

    Pepperidge Farm is recalling specific Goldfish Baked Snack Crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.

    Product
    Pepperidge Farm Goldfish Baked Snack Crackers, 20 Packs Variety Pack. Containing 10 Colors Packs, and 10 Flavor Blasted Xtra Cheddar Packs. Net Wt. 18 oz. (1.1 lbs) (510g) UPC 14100-04720.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2018·2018-08-15

    Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate

    Howmedica Osteonics Corp. is recalling 201 units of the rHead Radial Implant 6 mm Collar, Size 1, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2018·2018-08-15

    Howmedica Radial Head Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 170 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2018·2018-08-15

    Arjohuntleigh Q-Connect Scale Recall Due to Spreader Bar Detachment Risk

    Arjohuntleigh Magog is recalling Q-Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.

    Product
    Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1763-2018·2018-08-15

    Vitale Brothers Rye Bread Recalled for Undeclared Wheat

    Vitale Brothers Bakery is recalling 21 loaves of Rye bread sold in Michigan due to undeclared wheat, posing a risk to individuals with wheat allergies.

    Product
    Vitale Brothers Rye bread (1lb loaf) UPC1589410007
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2683-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 305 units of the rHead Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2018·2018-08-15

    Boston Scientific Guider Softip XF Guide Catheter Recalled for Polymer Degradation

    Boston Scientific is recalling Guider Softip XF Guide Catheters due to potential polymer material degradation. The recall affects 31,005 units distributed in the US and Canada.

    Product
    Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2696-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 121 Radio Capitellum Small, Right orthopedic implants because literature reviews indicate a higher revision rate than expected.

    Product
    Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide