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.

18426–18450 of 50407

  • HighFDA (Devices)·Z-0379-2022·2021-12-22

    Olympus EVIS EXERA II Duodenovideoscope Recalled for Contamination Risk

    Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.

    Product
    EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0280-2022·2021-12-22

    TJ Farms Select Frozen Cauliflower Recalled for Listeria

    FLAGSHIP FOOD GROUP LLC is recalling TJ Farms Select frozen cauliflower due to potential Listeria monocytogenes contamination. The affected product was distributed in Pennsylvania, Tennessee, and Wisconsin.

    Product
    Frozen cauliflower, TJ Farms Select brand, packaged in 16 oz. plastic bag. UPC 7 5544000604 3
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0321-2022·2021-12-22

    Country Time Pink Lemonade Powder Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Country Time Pink Lemonade powder drink mix in 19 oz., 63 oz., and 82.5 oz. packages due to potential glass and metal contamination.

    Product
    Country Time Pink Lemonade powder drink mix 19 oz. UPC 043000951149 63 oz. UPC 043000082188 82.5 oz. UPC 043000928615
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2022·2021-12-22

    Cook Flexor Check-Flo Introducer recalled for size mislabeling

    Cook Inc. is recalling the Flexor Check-Flo Introducer due to mislabeled packaging where 6FR devices may be labeled as 7FR or vice versa. This size mislabeling could result in selection of the wrong device size.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-0324-2022·2021-12-22

    Country Time "On The Go" Lemonade Drink Mix Powder Recall

    Kraft Heinz Foods Company is recalling Country Time "On The Go" Lemonade 10-pack drink mix powder due to potential glass and metal contamination in the product.

    Product
    Country Time "on the go" Lemonade 10 pack net wt. 6.7 oz. drink mix powder UPC 043000010983
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2022·2021-12-22

    SmartGown Breathable Surgical Gowns recalled for packaging seal defects

    Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.

    Product
    SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22038·2021-12-22

    Pearl River Propane Hoses Recalled for Fire Hazard Risk

    Pearl River propane hoses used with Flame King torches can swell and rupture, leaking propane gas and creating a fire hazard. About 43,000 units sold online from January through May 2021 are affected.

    Product
    Pearl River propane hoses used on propane torches and accessories
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise

    Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2022·2021-12-22

    Neuro Convenience Kit recalled due to expired injectable component

    Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.

    Product
    Neuro Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0333-2022·2021-12-22

    Tang Guava Pineapple Drink Mix Powder Recalled for Glass and Metal

    Kraft Heinz Foods Company is recalling Tang guava pineapple drink mix powder (18 oz.) due to potential glass and metal fragments in the product. Affected packages have a Best When Used By date of 8/13/2023.

    Product
    Tang guava pineapple drink mix powder 18 oz. UPC 043000064511
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0357-2022·2021-12-22

    Livia One Organic Daily Liquid Probiotics recalled for bacterial contamination

    Livia Global is recalling Livia One Organic Daily Liquid Probiotics in 2 oz. and 4 oz. bottles due to contamination with Pseudomonas aeruginosa, a bacterium that can cause illness.

    Product
    Livia One Organic Daily Liquid Probiotics; 2 oz. (59 ml) and 4 oz. (120 ml) UPC: 0 30915 10711 2 - 2 oz. 0 30915 10716 7 - 4 oz. Recommended use: Internal: Adults 4 droppers full daily. Children 12 yrs and under 1-2 droppers daily. Ingredients: Proprietary…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0373-2022·2021-12-22

    Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect

    Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2022·2021-12-22

    Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions

    Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2022·2021-12-22

    Smith & Nephew EVOS femur plates recalled for erroneous MRI instructions

    Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.

    Product
    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V00G000·2021-12-22

    Alamo Recalls 2012-2021 Schwarze CNG Street Sweepers for Fire Risk

    Alamo Group is recalling 2012-2021 Schwarze A7, A8, and A9 CNG street sweepers because debris accumulation against the exhaust system increases the risk of a fire.

    Product
    SCHWARZE — SCHWARZE A7 CNG STREET SWEEPER, A8 CNG STREET SWEEPER, A9 CNG STREET SWEEPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2022·2021-12-22

    MENTOR Saline-Filled Breast Implants Recalled for Deflation Risk

    Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.

    Product
    MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0320-2022·2021-12-22

    Kool-Aid Tropical Punch powder drink mix recalled for glass and metal contamination

    Kraft Heinz Foods Company is recalling Kool-Aid Tropical Punch powder drink mix in three sizes due to potential glass and metal contamination in the product.

    Product
    Kool-Aid Tropical Punch powder drink mix 19 oz. UPC 043000953501 63 oz. UPC 043000953501 82.5 oz. UPC 043000957400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2022·2021-12-22

    FDA Updates Instructions for Miami J Select Collar Device

    Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.

    Product
    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2022·2021-12-22

    Medline Vascular CDS Kit Recalled for Expired Saline Component

    Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.

    Product
    Major Vascular CDS Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0284-2022·2021-12-22

    Ripple Dairy-Free Plant-Based Milk Recalled for Bacillus Cereus

    Ripple Foods is recalling 48 fl oz bottles of Ripple Dairy-Free Plant-Based Milk due to the detection of Bacillus Cereus in one lot. The contamination was identified during an FDA investigation.

    Product
    Ripple Dairy-Free. As It Should Be 8g Plant Based Protein; Half the Sugar of Dairy Milk PET bottle with twist cap 50% More Calcium that Dairy Milk. Keep refrigerated. Fresh for 7-10 days after opening. 48 fl oz. (1.5 qt) ((1.42L) - 6 x 48 ox. bottles per case Ingredients…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0285-2022·2021-12-22

    Yeast Extract Ajirex Recalled for Potential Salmonella Contamination

    Mitsubishi International Food Ingredients is recalling Yeast Extract Ajirex in 15 kg bags due to potential Salmonella contamination. The product was distributed to Georgia, Illinois, Pennsylvania, and Texas.

    Product
    Yeast Extract Ajirex in 15 kg PE bag in carton box
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0374-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals

    Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Packaging Seal Defects

    Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
    Category
    Medical Device
    Distribution
    Distributed nationwide