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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12376–12400 of 13816

  • HighFDA (Devices)·Z-0514-2022·2022-01-26

    SonarMed AirWave Monitor Kit recall due to alarm and sensor detection failures

    Covidien is recalling 66 SonarMed AirWave Monitor Kits because the alarm may fail to sound and sensors may be incorrectly detected as disconnected, potentially causing the monitor to stop monitoring patients without alerting staff.

    Product
    SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0503-2022·2022-01-26

    VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results

    Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2022·2022-01-26

    Gentueri Viral Transport Medium Recalled Due to Turbidity and Discoloration

    Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM) nationwide due to visual turbidity and discoloration that may compromise diagnostic samples in transit.

    Product
    Gentueri Viral Transport Medium (VTM), Sterile, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2022·2022-01-26

    Cardinal Infant Heel Warmer recalled due to unapproved labeling changes

    Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.

    Product
    Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2022·2022-01-26

    FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error

    Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.

    Product
    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2022·2022-01-26

    Senior Living Nurse Call Systems Failing to Alarm Due to Memory Issue

    Stanley Security Solutions is recalling 11 Senior Living Arial Emergency and Nurse Call Systems because they fail to alarm due to increased memory consumption, potentially preventing nursing staff from responding to resident emergencies.

    Product
    Senior Living Arial Emergency and Nurse Call Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2022·2022-01-26

    ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall

    Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.

    Product
    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2022·2022-01-26

    Microbiological Reference Products Recalled for Bacterial Contamination

    Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.

    Product
    KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0510-2022·2022-01-26

    Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk

    Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.

    Product
    Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2022·2022-01-26

    Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error

    Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.

    Product
    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2022·2022-01-26

    Draeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses

    Draeger Medical recalls 26 Fabius MRI Anesthesia Machines due to incorrectly routed internal oxygen hoses. The misrouting can cause oxygen flow to deviate from set levels, risking inadequate patient oxygenation.

    Product
    Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2022·2022-01-26

    Medical Device Assay Kits Recalled for Potential Instrument Leakage

    Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.

    Product
    ARIES HSV 1&2 Assay, Part Number/REF 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2022·2022-01-26

    Infant Heel Warmers Recalled for Unauthorized Labeling Changes

    Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.

    Product
    Infant Heel Warmers w/strap, Reference # 989805603201 1223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0507-2022·2022-01-26

    Heel Snuggler devices recalled for labeling changes without FDA approval

    Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.

    Product
    Heel Snuggler, Reference # 989805603411 99047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2022·2022-01-26

    Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements

    Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.

    Product
    Infa-Therm Transport Mattress, Reference Number 989805616831 1015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2022·2022-01-26

    Medichoice Infant Heel Warmer recalled due to unapproved labeling changes

    Philips is recalling 2,925,800 Medichoice Infant Heel Warmer units because labeling was modified beyond the scope of FDA clearance. The devices cannot be sold without new 510(k) approval.

    Product
    Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0468-2022·2022-01-19

    Maquet Sevoflurane vaporizer filling recalled due to potential hydrogen fluoride exposure

    Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.

    Product
    Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2022·2022-01-19

    Subdermal Needle Electrode Corkscrew Recall: Risk of Blue Hub Detachment

    Technomed Europe is recalling 117,672 disposable subdermal needle electrodes due to risk of the blue hub detaching, potentially leaving the needle in the patient's scalp.

    Product
    Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2022·2022-01-19

    Medtronic Perfusion Kits Recalled: Missing Endotoxin Testing

    Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.

    Product
    Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2022·2022-01-19

    Flat Panel Detector May Display Abnormal Images During Surgical Procedures

    Canon Medical's flat panel detectors used in Alphenix surgical systems may display abnormal horizontal stripes and fail to recover by restarting, potentially causing operators to work without proper visual guidance during procedures.

    Product
    Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality Nationwide

    Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.

    Product
    SOMATOM Confidence -Computed tomography systems Model 10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2022·2022-01-19

    GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall

    DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2022·2022-01-19

    DePuy Joint Stem May Have Undersized Bore, Complicating Surgical Removal

    DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/or bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2022·2022-01-19

    CT Scanner Software Update Causes Head Image Quality Degradation

    Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.

    Product
    SOMATOM Definition Edge -Computed tomography system Model 10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2022·2022-01-19

    OCT Camera Laser Safety Shut-Off Malfunction Affects Three Units

    Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.

    Product
    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide