The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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12451–12475 of 27470

  • HighFDA (Devices)·Z-0673-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 92 units of IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2021·2020-12-30

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 261 IcePearl 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IcePearl" 2.1 CX L 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2021·2020-12-30

    Nova Ortho-Med Recalls Star 8 Rolling Walkers Due to Fork Detachment Risk

    Nova Ortho-Med is recalling Star 8 Rolling Walkers because the front fork may unscrew from the leg, creating instability and a risk of the fork falling off.

    Product
    Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0696-2021·2020-12-30

    Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk

    Zimmer Biomet is recalling 4,713 Spinal Rod Cutters because they may fracture during use. The devices were distributed domestically and internationally.

    Product
    Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 22,289 IceFORCE 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0659-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 740 IceFORCE 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2021·2020-12-30

    ICU Medical Spiros Administration Sets Recalled for Molding Defect

    ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.

    Product
    42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2021·2020-12-30

    Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 6,363 IceSphere 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceSphere" 1.5 CX 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2021·2020-12-30

    ICU Medical Recalls 30-inch IV Administration Sets Due to Molding Defect

    ICU Medical is recalling 325 units of 30-inch IV administration sets because a molding defect in the male luer may cause fluid leaks, potentially leading to infusion delays or contamination.

    Product
    30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 117 IcePearl 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    Three IcePearl" 2.1 CX Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2021·2020-12-30

    ICU Medical Recalls Appx 1.7 ml Bag Spike Due to Molding Defect

    ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.

    Product
    Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2021·2020-12-30

    ICU Medical Recalls Spinning Spiros and ChemoAccess Infusion Components

    ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid contamination or exposure to hazardous medications.

    Product
    Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2021·2020-12-30

    GA Health ScopeValet Guardian Disposable Endoscope Valves Recalled for Defects

    GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2021·2020-12-30

    ICU Medical Recalls Spinning Spiros Closed Male Luer Components

    ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.

    Product
    Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0641-2021·2020-12-30

    GA Health Recalls 11,000 Stopcon Disposable Endoscope Valve Sets

    GA Health Company Limited is recalling 11,000 Stopcon Disposable Endoscope Valve Sets because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2021·2020-12-30

    Beckman Coulter MicroScan Pos MIC Panel Type 34 Recalled for QC Failure

    Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because a portion of the lot failed quality control, potentially causing false elevated daptomycin results.

    Product
    MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2021·2020-12-30

    ICU Medical Recalls Spinning Spiros Syringes and Administration Sets

    ICU Medical is recalling specific syringes and administration sets with spinning Spiros components due to a molding defect that may cause fluid leaks.

    Product
    3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 93 units of IceRod 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2021·2020-12-30

    Boston Scientific Recalls IceRod He-Thaw Prostate Cryoablation Kits

    Boston Scientific is recalling 115 IceRod He-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" He-Thaw Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2021·2020-12-30

    B Braun APEX Compounding System Control Panel Module Recalled

    B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.

    Product
    APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide