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.

23976–24000 of 50435

  • HighFDA (Devices)·Z-0850-2020·2020-02-05

    Vitreq Recalls VitreQ 25G Injection Needles Due to Sterility Concerns

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

    Product
    VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2020·2020-02-05

    Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.

    Product
    iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0857-2020·2020-02-05

    Vitreq Bv Recalls VitreQ 23G Pick Needles Due to Sterility Concerns

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

    Product
    VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2020·2020-02-05

    RayStation Treatment Planning Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.

    Product
    RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2020·2020-02-05

    Johnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices

    Johnson & Johnson is recalling Healon GV PRO ophthalmic viscosurgical devices because they may be difficult to remove from the eye, potentially causing increased pressure or equipment clogging.

    Product
    Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-0561-2020·2020-02-05

    Essential Everyday Unbleached Flour Recalled Due to Salmonella Contamination

    UNFI General Corporate is recalling Essential Everyday Unbleached Flour after the product tested positive for Salmonella. The recall involves 1,440 bags distributed to one consignee.

    Product
    Essential Everyday, Unbleached Flour, Enriched All-Purpose Pre-Sifted, packaged in a 5lb paper bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0869-2020·2020-02-05

    LivaNova Recalls Cyberonics VNS Therapy AspireSR Generators for Battery Depletion

    LivaNova is recalling 745 Cyberonics VNS Therapy AspireSR Model 106 generators due to electrical leakage causing premature battery depletion.

    Product
    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ and Elite Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because potential leaks may trap fluid, causing incomplete washing of recovered blood.

    Product
    JAPAN LOW VOL(125ML) CS5 SET,LN 261J - 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2020·2020-02-05

    Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.

    Product
    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0904-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver Elite sets because cracks in the bowl core may trap fluid, causing incomplete washing of recovered blood.

    Product
    JAPAN CELL SAVER ELITE SET - 225ML - 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 (Devices)·Z-0902-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Fastpacks Due to Potential Bowl Cracks

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

    Product
    JAPAN CS ELITE FASTPACK, 225ML - 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 processed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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