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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12926–12950 of 13816

  • 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-2578-2021·2021-10-06

    Aesculap PAS-PORT Surgical Implant Recalled for Deployment Failure

    Aesculap Implant Systems is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM because the implant may fail to deploy during surgery, potentially requiring additional medical intervention.

    Product
    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
    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-2576-2021·2021-10-06

    Vysis CLL FISH Probe Kit may fail to detect genetic deletion

    Abbott is recalling Vysis CLL FISH Probe Kits that may not detect 13q deletions in patient samples. This could lead to missed diagnosis of a genetic abnormality used in cancer treatment planning.

    Product
    Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
    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-2561-2021·2021-10-06

    Fluid management system control unit display freeze during hysteroscopic procedures

    A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.

    Product
    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk

    B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.

    Product
    15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
    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-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-2550-2021·2021-10-06

    Outlook pump extension sets recalled due to leakage and dosing errors

    Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.

    Product
    ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
    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-2551-2021·2021-10-06

    Outlook V1500HP Pump Set Recalled for Cassette Leakage

    The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.

    Product
    V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2021·2021-10-06

    Cardiosave Rescue IABP may unexpectedly shut down during operation

    Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2557-2021·2021-10-06

    B. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays

    B. Braun Medical is recalling 768 units of Outlook Pump Set 3 infusion sets due to potential leakage that could delay or prevent complete medication delivery and increase risk of bloodstream infection.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2021·2021-10-06

    Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated

    Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.

    Product
    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2021·2021-10-06

    Blood Administration Pump Set Recalled Due to Leakage Risk

    B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.

    Product
    Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
    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-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-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-2600-2021·2021-10-06

    Patient Lift Device Stretch Leveller May Lose Horizontal Position Control

    Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.

    Product
    LikoStretch 1900 Model Number: 3156051 - 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-2591-2021·2021-10-06

    MOSAIQ Oncology Information System software defect reverts approved drug strength

    The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    17 states
  • 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-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