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.

30526–30550 of 50499

  • HighFDA (Devices)·Z-0083-2018·2017-11-15

    Teleflex Auto Endo5 Clip Applier Recalled for Clip Misalignment

    Teleflex Medical is recalling 13,710 units of the Auto Endo5 Automatic Hem-o-lok Clip Applier because clips may misalign, jam, or fall out of the device.

    Product
    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0360-2018·2017-11-15

    Market Basket Dark Chocolate Almonds Recalled for Undeclared Milk

    New American Food Products is recalling Market Basket Dark Chocolate Almonds because the product contains undeclared milk.

    Product
    Dark Chocolate Covered Almonds: Market Basket Dark Chocolate Almonds 11oz (311g), UPC: 049705169650
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0347-2018·2017-11-15

    21st Century Snack Foods Recalls Dark Chocolate Almonds for Undeclared Milk

    21st Century Snack Foods is recalling Dark Chocolate Almonds because the product contains undeclared milk, a major food allergen.

    Product
    21st CENTURY SNACK FOODS DARK CHOCOLATE ALMONDS Roasted Almonds Covered in Rich Dark Chocolate Net Wt. 6oz (170g) UPC: 0 30603 22854 9.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-0153-2018·2017-11-15

    Muriel's Cheesey Bacon Dip Recalled for Undeclared Milk Allergen

    E & E Enterprises is recalling Muriel's Cheesey Bacon Dip because the label failed to declare milk and specific FD&C colors.

    Product
    Cheesey Bacon Dip, Muriel's brand, dry mix, packaged in 1 pint glass jar. Cheesey Bacon Dip, Muriel's brand, dry mix, packaged in plastic bag, net wt. 1 oz. The label is read in parts: "***Ingredients: Onion, Bacon Bits (Soy Flour, Salt, Caramel Color, Soybean Oil), Powdered…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0075-2018·2017-11-15

    Terumo BCT Recalls Harvest Graft Delivery Packs Due to Seal Defect

    Terumo BCT is recalling 525 Harvest Graft Delivery Packs because some lots may lack a seal on the inner pouch, potentially compromising sterility.

    Product
    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2018·2017-11-15

    Lima Delta Cup Beater Positioner Recalled for Potential Welding Defects

    Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage during use.

    Product
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0353-2018·2017-11-15

    Giant Eagle Recalls Market District Coffee Beans for Undeclared Milk

    Giant Eagle is recalling Market District Coffee Beans Covered in Dark Chocolate due to undeclared milk. The product is distributed in five states.

    Product
    Market District Coffee Beans covered in Dark Chocolate; Net Wt. 8 OZ.; Contains Soy; May Contain: Milk Manufactured in a plant that processes wheat, peanuts, tree nuts and eggs.; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238-2809
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0076-2018·2017-11-15

    Sorin FlexFlow Venous Cannula Recalled for Sharpness Defect

    Sorin Group USA is recalling a specific lot of FlexFlow Venous Cannulas because they are sharper or pointier than expected.

    Product
    FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2018·2017-11-15

    Encore Medical Recalls Cobalt MV Bone Cement Due to Packaging Seal Loss

    Encore Medical is recalling 840 units of Cobalt MV Bone Cement because the sterile Tyvek packaging seal may be lost, potentially compromising sterility.

    Product
    Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0154-2018·2017-11-15

    Muriel's Cheesey Pizza Dip Recalled for Undeclared Milk Allergen

    E & E Enterprises is recalling Muriel's Cheesey Pizza Dip because the label fails to declare milk and specific FD&C colors.

    Product
    Cheesey Pizza Dip, Muriel's brand, dry mix, packaged in 1 pint glass jar. Cheesey Pizza Dip, Muriel's brand, dry mix, packaged in plastic bag, net wt. 1 oz.. The label is read in parts: "***Ingredients: Onion, Red & Green Peppers, Garlic, Cayenne, Powdered Cheese…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0078-2018·2017-11-15

    Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error

    Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD DR, Model D433, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0358-2018·2017-11-15

    Dark Chocolate Covered Ginger Recalled for Undeclared Milk

    New American Food Products is recalling specific dark chocolate covered ginger products because they contain undeclared milk.

    Product
    Dark Chocolate Covered Ginger: CVS Gold Emblem Dark Chocolate Covered Ginger 9oz (255g), UPC: 050428540220;Ocean State Candy Break Dark Chocolate Ginger 9oz (255g), UPC:024354501006
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0354-2018·2017-11-15

    Giant Eagle Recalls Market District Dark Chocolate Almonds for Undeclared Milk

    Giant Eagle is recalling Market District Almonds Covered in Dark Chocolate due to undeclared milk. The product is distributed in five states.

    Product
    Market District Almonds covered in Dark Chocolate; Net Wt. 8 OZ.; Contains Soy; May Contain: Milk Manufactured in a plant that processes wheat, peanuts, tree nuts and eggs.; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238-2809
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0087-2018·2017-11-15

    Epimed RX-2 COUDE Epidural Needle Recalled for Potential Sterility Seal Defect

    Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.

    Product
    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0070-2018·2017-11-15

    Zimmer Biomet Recalls Custom Titanium Knee Implant Due to Nickel Content

    Zimmer Biomet is recalling a custom titanium knee implant because it contained a nickel-containing screw, posing a risk to a patient with a nickel allergy.

    Product
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0067-2018·2017-11-15

    Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

    Encore Medical, Lp is recalling Cobalt HV with Gentamicin bone cement because the sterile Tyvek packaging may have lost its seal, potentially compromising sterility.

    Product
    Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2018·2017-11-15

    Epimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues

    Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.

    Product
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
    Category
    Medical Device
    Distribution
    13 states
  • HighNHTSA·17V726000·2017-11-14

    Isuzu and Chevrolet Trucks Recall Defective Fire Extinguishers

    Isuzu is recalling certain 2008-2018 Isuzu and Chevrolet trucks because the installed fire extinguishers may clog, require excessive force to activate, or detach, posing injury risks.

    Product
    ISUZU — ISUZU, CHEVROLET NRR, NQR, NPR XD, NPR HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18029·2017-11-14

    Simplified Wireless Recalls iHoverspeed Hoverboards Due to Fire Hazard

    Simplified Wireless is recalling about 900 iHoverspeed self-balancing scooters because their lithium-ion batteries can overheat, posing a risk of fire or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide