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.

15301–15325 of 53092

  • HighFDA (Devices)·Z-0229-2023·2022-11-23

    125 Series iGO2 Portable Oxygen Concentrator Recalled for Unapproved Adhesive

    DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.

    Product
    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0232-2023·2022-11-23

    BD Phoenix diagnostic panel misformulated minocycline causes false resistance reporting

    BD Phoenix PMIC/ID-107 diagnostic panels contain misformulated minocycline that may produce false antibiotic resistance results, potentially delaying appropriate patient treatment.

    Product
    BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2023·2022-11-23

    Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.

    Product
    CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2023·2022-11-23

    Philips Laser System may enter non-recoverable error state

    The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.

    Product
    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
    Category
    Medical Device
    Distribution
    30 states
  • HighNHTSA·22V877000·2022-11-23

    Daimler Trucks Recalls 2023 FCCC MT50E Vans Due to Battery Defect

    Daimler Trucks North America is recalling 2023 FCCC MT50E vans because an insufficient battery connection may cause sudden loss of drive power, increasing crash risk.

    Product
    FCCC — FCCC MT50E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23711·2022-11-23

    Green Sprouts Stainless Steel Bottles and Cups Recalled for Lead Hazard

    Green Sprouts is recalling approximately 10,500 stainless steel straw bottles, sippy cups, and sip & straw cups because the bottom base can break off, exposing a solder dot containing lead. Children who ingest lead can suffer adverse health effects.

    Product
    Green Sprouts Stainless Steel Straw Bottles, Sippy Cups and Sip & Straw Cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0061-2023·2022-11-23

    Phenoxybenzamine Hydrochloride Capsules Recalled for Failed Specifications

    Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.

    Product
    Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0160-2023·2022-11-23

    Similac Neosure Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac Neosure 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 14.5 million bottles distributed nationwide and internationally are affected.

    Product
    Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0231-2023·2022-11-23

    Progressa hospital bed compression links may bend during head raising

    Baxter Healthcare is recalling 248 Progressa bed systems. Compression links may bend when raising the head section, even with patients under 500 pounds.

    Product
    Hill-Rom Progressa Bed System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2023·2022-11-23

    Surgical Level 3 Gowns Recalled for Inadequate Fluid Protection

    Texas Medical Technology Inc. is recalling 100,000 Disposable Surgical Level 3 Gowns (sizes Large, XLarge, XXLarge) because the fabric fails to pass hydrostatic pressure tests, meaning blood and other body fluids may penetrate the gown.

    Product
    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2023·2022-11-23

    CareFusion Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion Genesis sterilization containers failed required aerosol challenge testing. The 1,143 affected units may not adequately sterilize surgical instruments.

    Product
    CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0230-2023·2022-11-23

    Spinal Decompression System Recalled for Potential Weld Breakage

    Boston Scientific is recalling 175 Superion Indirect Decompression System devices due to potential weld breakage at the spindle cap that may prevent proper deployment during implantation.

    Product
    Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2023·2022-11-23

    CareFusion sterilization containers fail aerosol challenge testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0064-2023·2022-11-23

    FDA Recalls Labetalol Injectable for Potential Cross-Contamination Risk

    FDA recalls Nephron's Labetalol HCl Injection vials due to manufacturing deviations that could cause cross-contamination. The recall affects 34,020 vials distributed nationwide.

    Product
    PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2023·2022-11-23

    Endo Stitch V-Loc surgical sutures recalled due to needle breakage

    Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.

    Product
    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V868000·2022-11-23

    GM Recalls 2019-2020 Cadillac XT4 for Rearview Camera Software Defect

    General Motors is recalling 2019-2020 Cadillac XT4 vehicles because the video processing module may lose communication with the rearview camera, reducing rear visibility and increasing crash risk.

    Product
    CADILLAC — CADILLAC XT4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0063-2023·2022-11-23

    Carvedilol Tablets 25 mg Recalled for Weight and Thickness Specification Failures

    Viatris Inc is recalling 2,794 bottles of Carvedilol Tablets 25 mg nationwide because the tablets exceed FDA specifications for weight and thickness. Patients should verify their lot number and contact their pharmacist if affected.

    Product
    Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0150-2023·2022-11-23

    Gem City Fine Foods Flourless Chocolate Torte Recalled for Undeclared Soy

    Gem City Fine Foods is recalling its GF Flourless Chocolate Torte due to mislabeling. The product was labeled as Triple Berry Streusel Cheesecake, leaving soy undeclared on the package.

    Product
    Gem City Fine Foods GF Flourless Chocolate Torte, 4 oz., frozen gluten free dessert, clear plastic package, UPC 855026001018, Gem City Fine Foods, LLC, 3403 S 1400 W, Suite C, W Valley City, UT 84119
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0212-2023·2022-11-23

    CareFusion Genesis Sterile Containers Recalled for Failed Sterilization Validation Testing

    CareFusion is recalling 308 units of Genesis sterilization containers that failed aerosol challenge testing required to ensure proper sterilization of surgical instruments. The containers were distributed in the US and multiple countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0164-2023·2022-11-23

    Similac Stage 1 infant formula recalled for seal integrity compromise

    Abbott Laboratories is recalling Similac Stage 1 infant formula due to compromised seal integrity that could lead to product spoilage. Affected batches were distributed across the U.S., Canada, and Latin America.

    Product
    Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0244-2023·2022-11-23

    Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall

    Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.

    Product
    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing

    Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.

    Product
    CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0156-2023·2022-11-23

    Similac 360 infant formula recalled for compromised seal integrity

    Abbott Laboratories is recalling Similac 360 Total Care infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The affected product has been widely distributed domestically and internationally.

    Product
    Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0208-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Validation Testing

    CareFusion V.Mueller GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The recall affects 319 units distributed in the US and internationally.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
    Category
    Medical Device
    Distribution
    0 states