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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

10851–10875 of 27470

  • HighFDA (Devices)·Z-2584-2021·2021-10-06

    Operating Room Table Rotational Lock May Fail Due to Hardware Defect

    The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.

    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-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-2552-2021·2021-10-06

    B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk

    B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.

    Product
    OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
    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-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
  • HighFDA (Devices)·Z-2549-2021·2021-10-06

    Outlook Pump Measured Volume Solution Set recalled for cassette leakage

    B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.

    Product
    Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2021·2021-10-06

    Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use

    Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.

    Product
    The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2547-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk

    B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.

    Product
    60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
    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-2590-2021·2021-10-06

    Mobile X-Ray System Recalled for Unexpected Column Motion During Parking

    GE Healthcare is recalling the AMX Navigate Mobile X-Ray System due to an unexpected column motion defect that occurs during parking operations. Three units distributed in the United States are affected.

    Product
    AMX Navigate Mobile X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2574-2021·2021-10-06

    NAMIC Angiographic Manifolds Recalled for Potential Sterile Barrier Compromise

    Medline Industries recalled 816,420 NAMIC Angiographic Manifolds due to potential microscopic pinholes in sterile pouches that could compromise device sterility. No injuries reported.

    Product
    NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold,
    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-2569-2021·2021-10-06

    Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance

    Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.

    Product
    BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2021·2021-10-06

    LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed

    Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.

    Product
    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2021·2021-10-06

    Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery

    B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.

    Product
    Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
    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-2548-2021·2021-10-06

    Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk

    B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.

    Product
    10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
    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-2579-2021·2021-10-06

    PAS-PORT Proximal Anastomosis Device recalled for deployment failure risk

    Aesculap Implant Systems is recalling the PAS-PORT Proximal Anastomosis Device because the implant may fail to deploy successfully, potentially requiring additional medical intervention during surgery.

    Product
    PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
    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-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-2581-2021·2021-10-06

    Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements

    AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.

    Product
    AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
    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-2598-2021·2021-10-06

    Medical Device: FlexoStretch Patient Lift Leveller May Lose Function During Patient Transfer

    Hill-Rom's FlexoStretch Model 3156057 patient lift device may lose the ability to maintain horizontal positioning during patient transfer, risking patient falls. The FDA Class II recall affects 129 units distributed worldwide.

    Product
    FlexoStretch Model Number: 3156057 - 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-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