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.

24601–24625 of 50442

  • HighFDA (Devices)·Z-0204-2020·2019-10-30

    Siemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2020·2019-10-30

    Rifton E-Pacer Powered Lift Device Recalled for Buckle Fatigue Failure

    Community Products, LLC is recalling 167 Rifton E-Pacer powered lift devices because a design change makes the load-bearing buckle springs susceptible to fatigue failure.

    Product
    Rifton E-Pacer, SKU K660, powered lift device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0054-2020·2019-10-30

    Tia Rita's Cornbread Mix Recalled for Undeclared Wheat Allergen

    The Truck Farm, LLC is recalling Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix because the product contains wheat flour but does not declare wheat on the label.

    Product
    Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix. Packaged in 13 oz (380 g) sealed plastic bags with paper label stapled over the top edge of each package, 12 packages per case. UPC 44107 10062. Mfg. by The Truck Farm, LLC. Las Cruces, NM 88005.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues

    Andover Healthcare Inc. is recalling 1,798 cases of sterile Co-Flex NL 3-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0074-2020·2019-10-30

    Koppers Chocolate Gummy Bears Recalled for Missing Milk Allergen Labeling

    The Newark Nut Store is recalling Koppers Chocolate Dark Chocolate Gummy Bears because the packaging fails to list milk as an allergen.

    Product
    Koppers Chocolate Dark Chocolate Gummy Bears, 4oz (113g) retail package, metallized foil resealable pouch, 12 pouches per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0188-2020·2019-10-30

    Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0171-2020·2019-10-30

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 47,152 Plum 360 Infusion Systems because a software malfunction can cause the device to become inoperable with a blank screen when used with a MedNet Custom Drug Library.

    Product
    Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0062-2020·2019-10-30

    Dole Crushed Pineapple Recalled for Potential Plastic Pieces

    Dole Packaged Foods is recalling specific lots of crushed pineapple due to the potential presence of foreign plastic pieces.

    Product
    Dole Crushed Pineapple in 100% pineapple juice Manufactured For Dole Packaged Foods, LLC Westlake Village, CA 91361 Product of The Philippines UPC 3890000613
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0205-2020·2019-10-30

    Siemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.

    Product
    Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0181-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect

    Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings

    Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" wound dressings due to incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2020·2019-10-30

    Baxter Recalls EXACTAMIX Empty EVA TPN Bags Due to Leak Risk

    Baxter Healthcare is recalling EXACTAMIX Empty EVA TPN bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2020·2019-10-30

    Luminex xTAG Respiratory Viral Panel Recalled for False Negative Results

    Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.

    Product
    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0206-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled Due to Loose Neck Bushing

    Candela is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.

    Product
    Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0191-2020·2019-10-30

    IrriMAX Recalls Irrisept Wound Debridement System Due to Seal Defect

    IrriMAX Corporation is recalling 1,031 cases of Irrisept Wound Debridement and Cleansing Systems because a potential defect in the sterile pouch seal may result in a lack of sterility assurance.

    Product
    Irrisept Wound Debridement and Cleansing System. 12 units per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0073-2020·2019-10-30

    Trails End Sweet and Savory Collection Recalled for Undeclared Nuts

    Weaver Fundraising is recalling the Trails End Sweet and Savory Collection due to inaccurate nutrition facts and undeclared almonds, cashews, and pecans.

    Product
    Trails End Sweet and Savory Collection, containing White Cheddar cheese Corn (5 oz.), Butter Toffee Carmel Corn (20 oz.), and Chocolatey Caramel Crunch (15 oz.) each in individual foil bags packaged together in variety box
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0190-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles from the PORT-A-CATH II system because they may be occluded or blocked.

    Product
    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0059-2020·2019-10-30

    Shirakiku Buckwheat Noodles Recalled for Undeclared Fish Allergens

    Wismettac Asian Foods is recalling Shirakiku Buckwheat Noodles because the dipping sauce contains undeclared tuna and fails to list fish as an allergen.

    Product
    Shirakiku Buckwheat Noodles Yamaimo Soba With Concentration Soup Base, 435G SK, UPC 074410455200 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0174-2020·2019-10-30

    Medline Semi-Rigid Suction Canister Lid Recall for Fragmentation Risk

    Medline Industries is recalling Semi-Rigid Suction Canisters because the lids may fragment during use, posing a risk to patients and healthcare workers.

    Product
    Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V777000·2019-10-29

    Prevost Recalls 2020 Coaches Due to Dash Brightness Control Defect

    Prevost is recalling 110 specific 2020 coaches because a missing component prevents drivers from adjusting dash brightness, potentially reducing visibility at night.

    Product
    PREVOST — PREVOST H3-45, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide