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 deaths or serious injuries are reported, 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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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12951–12975 of 13837

  • HighFDA (Devices)·Z-2575-2021·2021-10-06

    NAMIC Stopcocks Recalled Due to Potential Sterile Barrier Breach

    Medline Industries is recalling NAMIC Stopcocks due to potential sterile barrier breaches from microscopic pinholes in sterile pouches, which could allow non-sterile conditions.

    Product
    NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2021·2021-10-06

    Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing

    B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.

    Product
    Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2021·2021-10-06

    B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery

    B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.

    Product
    Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2021·2021-10-06

    Outlook Pump IV Sets Recalled for Leakage and Infection Risk

    B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.

    Product
    Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2021·2021-10-06

    Corin MetaFix Hip Stem Recalled Due to Potential Packaging Damage

    Corin Ltd is recalling Corin MetaFix Hip Stem, Size 1 devices due to potential physical and water damage to packaging that could compromise device sterility and cause contamination.

    Product
    Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2021·2021-10-06

    Anesthesia Flow Sensors Recalled for Tube Damage and Potential Gas Leaks

    GE Healthcare is recalling approximately 310,000 replacement flow sensors for anesthesia machines manufactured before June 2021. The sensors may have damaged tubes that leak, causing incorrect anesthesia delivery to patients.

    Product
    Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2021·2021-10-06

    Operating Room Table Rotational Lock May Fail to Function

    Deerfield Imaging operating room tables (ORT200/300) may have a mechanical defect in the rotational lock, preventing it from changing between locked and unlocked states. This could affect patient positioning during procedures.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2021·2021-10-06

    Radiation therapy planning software can save contours to wrong image set

    Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected treatment plans.

    Product
    Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2021·2021-10-06

    Corin Trinity Dual Mobility Hip Implant Components Recalled for Sterility Loss Risk

    Corin Ltd is recalling specific Trinity Dual Mobility hip implant components due to packaging damage that may compromise sterility. The affected products were distributed to medical facilities in nine states.

    Product
    Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2021·2021-10-06

    Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.

    Product
    Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2021·2021-10-06

    Patient lift device may lose horizontal positioning control, creating fall risk

    The OctoStretch with Stretch Leveller may lose its ability to keep patients horizontal during lifting, risking patient falls. 440 units were distributed worldwide.

    Product
    OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2021·2021-10-06

    Outlook Pump IV Set Recalled Due to Cassette Leakage and Infection Risk

    B. Braun Medical is recalling Outlook Pump IV Sets due to cassette leakage that may delay medication delivery and cause incomplete dosing or bloodstream infections.

    Product
    OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2021·2021-10-06

    Operating room table rotational lock may fail to maintain position

    The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2021·2021-10-06

    Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk

    B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.

    Product
    OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2021·2021-10-06

    Patient lift devices may lose ability to maintain horizontal positioning during transfers

    Hill-Rom LikoStretch Mod 600 IC patient lift devices may fail to maintain patients in a horizontal position while lifting, potentially causing patients to slide or fall.

    Product
    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2021·2021-10-06

    Corin Unity Knee Patella components recalled due to packaging damage

    Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US states in July 2021.

    Product
    Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2021·2021-10-06

    Stretch Leveller Model 3156200 May Lose Horizontal Position Control

    Hill-Rom's Stretch Leveller Model 3156200 may lose the ability to maintain patients in a horizontal position during lifting, potentially causing patients to slide backward or fall from the lift sheet.

    Product
    Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2572-2021·2021-10-06

    Olympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated

    Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.

    Product
    BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2617-2021·2021-10-06

    Xcela PICC catheter mislabeled with incorrect size designation

    Angiodynamics is recalling Xcela PICC catheters where units labeled as 5F are actually 4F. The labeling discrepancy between labeled and actual product size could affect clinical device selection.

    Product
    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2594-2021·2021-10-06

    uEXPLORER PET/CT System Workflow Freeze Recall

    The uEXPLORER PET/CT System is being recalled because the EXAM acquisition workflow may freeze after canceling a PET scan. Affected systems may experience workflow interruptions during diagnostic imaging.

    Product
    uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2485-2021·2021-10-06

    Blood collection tubes recalled due to potential clotting defect

    Greiner Bio-One North America is recalling VACUETTE blood collection tubes (6 ml K2E) because they may experience a clotting issue. Approximately 962,400 tubes were distributed across 15 US states and Canada.

    Product
    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2568-2021·2021-10-06

    Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance

    Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.

    Product
    BF-P60 OES Bronchofiberscope, Model No. BF-P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2593-2021·2021-10-06

    uMI 550 PET Imaging System Software Workflow May Occasionally Freeze

    The uMI 550 medical imaging system may occasionally freeze during the EXAM acquisition workflow when a PET scan is canceled. This can disrupt clinical operations.

    Product
    uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, c
    Category
    Medical Device
    Distribution
    Distributed nationwide