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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15726–15750 of 40287

  • HighFDA (Devices)·Z-0678-2021·2020-12-30

    Boston Scientific Recalls IceRod MRI Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 3,894 IceRod 1.5 MRI 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 MRI 90¿ Cryoablation Needle¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2021·2020-12-30

    ICU Medical Recalls Spiros Male Luer Devices Due to Molding Defect

    ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid contamination, or exposure to hazardous medications.

    Product
    Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2021·2020-12-30

    GE Healthcare Recalls Three Revolution CT Systems for Protocoling Errors

    GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.

    Product
    Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2021·2020-12-30

    ICU Medical Recalls Spiros and Clave IV Administration Sets

    ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.

    Product
    5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2021·2020-12-30

    GA Health STOPCON Disposable Valves Recalled for Sticky or Broken Suction Buttons

    GA Health Company Limited is recalling 25,000 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 9,353 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2021·2020-12-30

    Biomet Vanguard 360 Knee Augment Recall Due to Incorrect Bolts

    Biomet is recalling 21 units of Vanguard 360 Revision System Posterior Augments because tibial bolts were packaged instead of femoral bolts, which may delay knee arthroplasty procedures.

    Product
    Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2021·2020-12-30

    Integra Recalls Mislabeled Bactiseal Endoscopic Ventricular Catheters

    Integra LifeSciences is recalling 17 Bactiseal Endoscopic Ventricular Catheters due to mislabeling. The devices were incorrectly identified as a different catheter model.

    Product
    Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0645-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect

    GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0722-2021·2020-12-30

    Siemens Atellica GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling Atellica GGT Reagent because it may show repeatability imprecision outside performance data on some analyzers.

    Product
    Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2021·2020-12-30

    Baxter Spectrum IQ Infusion System Recalled for Potential Software Error

    Baxter Healthcare is recalling Spectrum IQ Infusion Systems with Dose IQ Safety Software due to a potential software error during programming.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0724-2021·2020-12-30

    Integra Recalls Mislabeled Bactiseal Ventricular Catheters for Hydrocephalus Treatment

    Integra LifeSciences is recalling 85 units of Bactiseal Ventricular Catheters that were mislabeled as Endoscopic Ventricular Catheters. The error involves swapped product labels for part numbers 823073 and 823087.

    Product
    Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0677-2021·2020-12-30

    IceEDGE Cryoablation Needle gas leak recall issued by FDA

    Boston Scientific Corporation recalled 525 IceEDGE cryoablation needles due to reported gas leaks in the needle shaft, affecting nationwide distribution.

    Product
    IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2021·2020-12-30

    Biocomposites Recalls Stimulan Kit 10cc Due to Mislabeled Product

    Biocomposites, Ltd. is recalling 54 boxes of Stimulan Kit 10cc, Model 600-010, because the product is mislabeled. The recall affects units distributed in the US, Puerto Rico, and Costa Rica.

    Product
    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0698-2021·2020-12-30

    AMT ENFit-to-Stepped Male Adapter Recalled for Incorrect Pouch Labels

    Applied Medical Technology Inc is recalling specific lots of ENFit-to-Stepped Male adapters because the inner pouches may have incorrect labels, although the outer boxes are correct.

    Product
    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2021·2020-12-23

    DePuy Synthes 15.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0579-2021·2020-12-23

    DePuy Synthes 14.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 14.0MM Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0571-2021·2020-12-23

    DePuy Synthes 10.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.0MM Reamer Heads for RIA 2 because breakage exceeds expected rates, causing potential tissue or bone damage.

    Product
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
    Category
    Medical Device
    Distribution
    Distributed nationwide