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.

45451–45475 of 50512

  • HighFDA (Food)·F-1709-2012·2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of cinnamon Xylishield gum because the ingredients label failed to list soy, a major allergen.

    Product
    Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1911-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is recalling ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations due to a Field Safety Notice.

    Product
    ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is recalling Luster and Ultima LX hip stems implanted with metal-on-metal articulations due to a field safety notice.

    Product
    LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1684-2012·2012-07-11

    Newly Weds Foods Recalls Turkey Marinade Due to Salmonella Risk

    Newly Weds Foods is recalling 50 lb. bags of Turkey Dripping Type Marinade X1 because it was made with a yeast extract contaminated with Salmonella.

    Product
    Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1920-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Use

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1696-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Yellow 6

    Mexicantown Wholesale is recalling 26 units of Mexican Sweet Bread imported by El Campeon Leamington due to undeclared Yellow 6.

    Product
    MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1919-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Components

    DePuy Orthopaedics issued a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1700-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Yellow 6 Dye

    Mexicantown Wholesale is recalling Tortugas Mexican Sweet Bread due to undeclared Yellow 6 dye. The recall affects 26 products distributed in Canada.

    Product
    TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1704-2012·2012-07-11

    Mexican Bread Recalled for Undeclared Food Dyes

    Mexicantown Wholesale recalled Conchas (Mexican Bread) in Canada due to undeclared Yellow #5 and Yellow #6.

    Product
    CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1702-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Artificial Food Dyes

    Mexicantown Wholesale recalled Polvorones Con Fresa (Mexican Sweet Bread) for containing undeclared Yellow #6 and Red #40.

    Product
    POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1912-2012·2012-07-11

    DePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use

    DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12218·2012-07-10

    Bosch Recalls SkilSaw Miter Saws Due to Laceration Hazard

    Bosch is recalling approximately 22,149 SkilSaw 10-inch compound miter saws because the lower guard can break and contact the blade, posing a laceration hazard.

    Product
    Miter Saw
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V321000·2012-07-09

    Glaval Buses Recalled for Wheelchair Lift Roll Stop Latch Defect

    Glaval is recalling certain buses equipped with Braun wheelchair lifts because roll stop latches may become bent or misaligned, posing a fall risk to occupants.

    Product
    GLAVAL — GLAVAL, GLAVAL BUS UNIVERSAL, TITAN, CONCORDE II, TITAN II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2012·2012-07-04

    Hartmann Sterile Gauze Sponges Recalled for Sterile Barrier Defects

    Hartmann USA is recalling specific lots of Econolux sterile gauze sponges because micro holes were detected in the sterile barrier system, potentially compromising sterility.

    Product
    Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2012·2012-07-04

    Colgate Adult Motion Battery Toothbrush Recalled for Battery Cap Defect

    Colgate-Palmolive is recalling 6,006 Adult Motion Battery Toothbrushes because the battery cap may blow off the handle.

    Product
    Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance found on the inner surface of some tips can be dislodged during use.

    Product
    Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some tips that could dislodge.

    Product
    CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2012·2012-07-04

    Ethicon Surgiflo Hemostatic Matrix Kit Recalled for Potential Non-Sterility

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits with Thrombin because an undetected air leak during manufacturing may have compromised the sterility of the thrombin component.

    Product
    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or…
    Category
    Medical Device
    Distribution
    Distributed nationwide