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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12326–12350 of 13837

  • HighFDA (Devices)·Z-0615-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare MR superconducting magnets in SIGNA MRI systems may have cryogen ventilation systems that do not meet safety venting requirements. Approximately 17,228 systems are affected.

    Product
    GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2022·2022-02-16

    GE SIGNA MRI Systems Recalled for Cryogen Ventilation Defect

    GE Healthcare is recalling 17,228 MRI systems with a potential cryogen ventilation system defect that may not meet regulatory venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2022·2022-02-16

    Orthopedic knee replacement component recalled for adhesive residue contamination

    DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.

    Product
    ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2022·2022-02-16

    Baxter PD Transfer Sets may leak or crack from common cleaning products

    Certain cleaning products can damage Baxter MiniCap Extended Life PD Transfer Sets, causing them to leak or crack. Baxter is recalling approximately 61,290 units sold worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2022·2022-02-16

    Baxter CAPD Transfer Sets May Leak if Cleaned with Certain Chemicals

    Baxter Healthcare is recalling CAPD MiniCap Transfer Set II units worldwide because certain cleaning products containing chemicals like hydrogen peroxide, bleach, and solvents may cause the sets to leak or crack.

    Product
    Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0605-2022·2022-02-16

    GE Healthcare MR system magnets recalled due to cryogen ventilation defect

    GE Healthcare is recalling 17,228 MR superconducting magnet components due to a cryogen ventilation system that may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Potential Cryogen Ventilation Defect

    GE Healthcare is recalling approximately 17,228 SIGNA Creator and Explorer MRI systems due to potential defects in their cryogen ventilation systems that may not meet required venting standards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2022·2022-02-16

    Baxter MiniCap PD Transfer Set Recall—Damage from Cleaning Products

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets worldwide because cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents may cause the devices to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0601-2022·2022-02-16

    GE Healthcare MRI Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2022·2022-02-16

    GE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall

    GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2022·2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling Discovery MR750w 3.0T MRI systems due to cryogen ventilation systems that may not meet FDA venting requirements. Approximately 17,228 devices were affected.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2022·2022-02-16

    GE Healthcare MRI systems recalled for cryogen ventilation system defect

    GE Healthcare Discovery MR450 MRI systems may have cryogen ventilation systems that do not meet required venting standards. The recall affects approximately 17,228 devices distributed in the U.S. and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2022·2022-02-16

    Universal Chuck Surgical Instrument Handle May Detach and Release Ball Bearings

    The Universal Chuck instrument handle may loosen and release ball bearings onto the surgical field. If not recovered, these bearings could delay surgery and potentially cause infection or tissue damage.

    Product
    Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2022·2022-02-16

    Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling

    Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.

    Product
    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccan
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0567-2022·2022-02-16

    Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits

    A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0582-2022·2022-02-16

    Medical device reference standard contaminated with bacterial species

    Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.

    Product
    KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2022·2022-02-16

    LYSO Disk microorganism culture device mislabeled with incorrect strain

    Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.

    Product
    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0621-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0581-2022·2022-02-16

    Medical device lot number misprinted on packaging

    Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.

    Product
    KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0481-2022·2022-02-09

    COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale

    Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.

    Product
    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0480-2022·2022-02-09

    COVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval

    CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.

    Product
    CovClear COVID-19 Rapid Antigen Test, ATG 900-031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0529-2022·2022-02-09

    Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure

    Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.

    Product
    Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0530-2022·2022-02-09

    Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures

    Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0550-2022·2022-02-09

    OXY-1 System Console Experiences Power Interruption During Use

    OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.

    Product
    OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0552-2022·2022-02-09

    Premier Rotaclone Medical Device Recalled Due to Improper Storage Conditions

    Medline Industries is recalling 34 units of the Premier Rotaclone (Lot 696004N116) due to improper storage in temperature-controlled settings instead of required refrigeration. This may affect device performance or safety.

    Product
    Premier Rotaclone, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide