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.

24026–24050 of 50473

  • HighFDA (Devices)·Z-0858-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 25G Pick Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G Pick Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2020·2020-02-05

    Haemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks

    Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0565-2020·2020-02-05

    ASK Foods Recalls Krab Salad Due to Potential Metal Contamination

    ASK Foods Inc. is recalling 5 lb. containers of Krab Salad in Maryland because the product may contain metal pieces.

    Product
    ASK Foods Inc., KRAB SALAD, NET WT. 5 LB (2.27 kg), Plastic tub with a plastic lid,Keep Refrigerated, 2786-140
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0906-2020·2020-02-05

    Haemonetics Recalls Japan DISP SETs Due to Potential Bowl Cracks

    Haemonetics is recalling 1,584 Japan DISP SETs because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2020·2020-02-05

    Vitreq 27G Blunt Needles Recalled for Potential Sterility Compromise

    Vitreq Bv is recalling VitreQ 27G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2020·2020-02-05

    Vitreq Recalls VitreQ 27G Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 27G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 25G Blunt Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2020·2020-02-05

    Vitreq 23G Needles Recalled for Potential Sterility Compromise

    Vitreq Bv is recalling VitreQ 23G needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2020·2020-02-05

    Mindray BA-800M Chemistry Analyzer Recalled for Gas Spring Failure Risk

    Mindray is recalling seven BA-800M Chemistry Analyzers because a gas spring on the protective cover may fail, posing a low risk of impact injury to users.

    Product
    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0888-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver 5/5+ Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2020·2020-02-05

    Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping

    Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.

    Product
    Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2020·2020-02-05

    Vitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 20G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2020·2020-02-05

    ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices

    ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.

    Product
    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0917-2020·2020-02-05

    Bard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error

    Bard Peripheral Vascular Inc. is recalling 286 units of Conquest 40 PTA Dilation Catheters because packaging incorrectly listed the balloon size, posing a risk of vessel injury.

    Product
    Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0891-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ Bowl Kits because they may leak, trapping fluid and causing incomplete washing.

    Product
    Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2020·2020-02-05

    Zimmer Biomet Recalls ASI 2.0 Calcar Trimmer Shafts Due to Mating Failure

    Zimmer Biomet is recalling 67 units of ASI 2.0 Calcar Trimmer Shafts because the shaft end may fail to mate effectively with the broach.

    Product
    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Potential Leaks

    Haemonetics is recalling Cell Saver bowl sets because cracks may cause leaks and incomplete blood washing.

    Product
    Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0573-2020·2020-02-05

    Kindroot Adaptogems Lozenges Recalled for Undeclared Fish Allergen

    Kindroot LLC is recalling Peach Blossom plant lozenges because the label failed to list fish as the source of collagen peptides.

    Product
    kindroot adaptogems; Peach Blossom Plant lozenges for lit looks. 20 lozenges net wt. 2.6 oz. 74 g - Dietary Supplement UPC: 8 60000 30544 0 Ingredients: Marine collagen Peptides, Ashwagandha Root Extract (organic). Other ingredients: Organic Brown Rice Syrup, malic…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0847-2020·2020-02-05

    Vitreq 25G Blunt and Brush Needles Recalled for Sterility Risk

    Vitreq Bv is recalling VitreQ 25G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20T002000·2020-02-04

    Goodyear Recalls Fortera HL Tires Due to Belt Separation Risk

    Goodyear is recalling specific Fortera HL tires because a manufacturing issue may cause belt separation, increasing the risk of a crash.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V054000·2020-01-31

    Triple E Recalls 2020 Motorhomes Due to Propane Line Defects

    Triple E is recalling 237 2020 Unity, Wonder, and Serenity motorhomes because twisted or kinked propane lines may leak and cause a fire.

    Product
    WONDER — WONDER, UNITY, SERENITY W24RTB, W24MB, W24FTB, U24MB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V057000·2020-01-31

    Volkswagen Recalls 2018 Atlas Vehicles Due to Air Bag Sensor Defect

    Volkswagen is recalling 2018 Atlas vehicles because an incorrectly manufactured air bag sensor may delay or disable deployment, increasing injury risk in crashes.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20716·2020-01-30

    K-Apparel Recalls Children's Lounge Pants Due to Burn Hazard

    K-Apparel is recalling about 2,200 TINFL children's lounge pants because they fail federal flammability standards, posing a burn risk to children.

    Product
    Children's Lounge Pants
    Category
    Consumer Product
    Distribution
    Distributed nationwide