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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27076–27100 of 27681

  • SevereFDA (Devices)·Z-0274-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Faults

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that could cause unintended pump stoppage during surgery.

    Product
    S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0275-2013·2012-11-14

    Sorin C5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA recalled two Sorin C5 Perfusion Systems due to a motor controller fault that could cause pump stoppage during surgery.

    Product
    Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2013·2012-11-14

    Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error

    Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.

    Product
    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0268-2013·2012-11-14

    Kerr Recalls AlgiNot Dental Impression Material Due to Curing Defect

    Kerr Corporation is recalling AlgiNot dental impression material because it may cure harder than expected, potentially causing tooth fractures in patients with loose teeth.

    Product
    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2013·2012-11-14

    Kimberly-Clark Recalls MicroCool Sterile Surgical Gowns Due to Seal Defects

    Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.

    Product
    MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0196-2013·2012-11-14

    Spacelabs Healthcare Recalls Xprezzon Bedside Monitor Touchscreen Displays

    Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.

    Product
    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2013·2012-11-14

    Sunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination

    Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.

    Product
    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2013·2012-11-14

    Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk

    Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.

    Product
    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0257-2013·2012-11-14

    Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure

    Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.

    Product
    ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2013·2012-11-14

    FDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips

    Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0208-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0174-2013·2012-11-07

    Ventlab Infant Resuscitator Recalled for Possible Volume Leakage

    Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.

    Product
    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0172-2013·2012-11-07

    Ventlab Stat-Check Resuscitator Recalled for Possible Volume Leakage

    Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0171-2013·2012-11-07

    Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage

    Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0170-2013·2012-11-07

    Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage

    Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during bag compressions.

    Product
    Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0177-2013·2012-11-07

    Ventlab Premium Small Child Resuscitator Recalled for Valve Leakage

    Ventlab Corporation is recalling 14,602 Premium Small Child Resuscitators due to possible volume leakage through the inlet valve during compressions.

    Product
    Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0169-2013·2012-11-07

    Elekta MOSAIQ Medical Record System Recalled for Treatment Data Error

    Elekta, Inc. is recalling MOSAIQ electronic medical record systems because a user error led to a patient being seriously mistreated.

    Product
    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0180-2013·2012-11-07

    Ventlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage

    Ventlab is recalling 14,602 AirFlow Infant Resuscitators because the inlet valve may leak air during compressions, potentially compromising respiratory support.

    Product
    AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0178-2013·2012-11-07

    Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage

    Ventlab Corporation is recalling 14,602 Premium Small Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0175-2013·2012-11-07

    Ventlab AirFlow Resuscitator Recalled for Inlet Valve Leakage

    Ventlab Corporation is recalling 14,602 AirFlow Resuscitators due to possible volume leakage through the inlet valve during bag compressions.

    Product
    AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0124-2013·2012-11-07

    HeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction

    Heartsine is recalling 81,982 Samaritan 300/300P PAD devices because they may turn on or off unexpectedly, potentially preventing therapy delivery during cardiac arrest.

    Product
    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0176-2013·2012-11-07

    Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage

    Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during use.

    Product
    Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2013·2012-11-07

    Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage

    Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.

    Product
    AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0179-2013·2012-11-07

    Ventlab Infant Resuscitator Recalled for Possible Volume Leakage

    Ventlab Corporation is recalling 14,602 infant resuscitators due to possible volume leakage through the inlet valve during bag compressions.

    Product
    Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly…
    Category
    Medical Device
    Distribution
    Distributed nationwide