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.

Filters

Agency

Category

Minimum severity

Clear filters

11751–11775 of 13717

  • HighFDA (Devices)·Z-1071-2022·2022-05-18

    TMJ Arthroscopy Drape incorrectly labeled latex-free when containing latex

    Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.

    Product
    TMJ Arthroscopy Drape, 85''x 96''
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2022·2022-05-18

    ACS Cath Lab Packs Sterilized with Excess Ethylene Oxide

    American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.

    Product
    ACS Cath Lab Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1051-2022·2022-05-18

    CABG Surgical Kit Recall Due to Improper Shipping Box Packing

    ROi CPS LLC is recalling 85 Regard brand CABG Packs due to incorrect packing into shipping boxes. One North Carolina healthcare facility received the affected kits.

    Product
    Regard brand CABG Pack A and B - Spartanburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1060-2022·2022-05-18

    First Aid Kits and Cabinets Recalled for Manufacturing Deviations

    Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.

    Product
    The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Fir
    Category
    Medical Device
    Distribution
    36 states
  • LowFDA (Devices)·Z-1056-2022·2022-05-18

    Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers

    Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.

    Product
    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0944-2022·2022-05-11

    COVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization

    SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.

    Product
    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2022·2022-05-11

    Johnson & Johnson Tray Ring Covers Recalled for Sterility Barrier Breach

    Johnson & Johnson Surgical Vision is recalling tray ring covers (Model OM271000) worldwide due to a potential breach in the sterility barrier that could allow contamination.

    Product
    TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2022·2022-05-11

    Azurion Medical Imaging System Software Defect Alters Dose Parameters

    A software defect in Philips Azurion imaging systems causes the Patient Type to change unexpectedly during study initiation, altering dose control parameters without operator notification.

    Product
    Azurion systems with software release R1.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2022·2022-05-11

    In Vitro Diagnostic Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient results.

    Product
    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2022·2022-05-11

    Siemens ADVIA Centaur Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading clinicians to misinterpret patient results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2022·2022-05-11

    First Aid Kits Recalled Due to Defective Acetaminophen

    ASO LLC is recalling approximately 73,668 first aid kits sold under Equate, Meijer, and Care Science brands that contain previously recalled acetaminophen. Affected kits were distributed nationwide.

    Product
    First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2022·2022-05-11

    Estradiol Diagnostic Test Recall: Risk of Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.

    Product
    Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2022·2022-05-11

    Baxter Flo-Thru Intraluminal Shunt Recall for Potential Foreign Matter

    Baxter Healthcare is recalling Flo-Thru Intraluminal Shunts due to potential foreign matter contamination. The recall involves 300 devices distributed in the U.S. and internationally.

    Product
    Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1029-2022·2022-05-11

    Robotic-Assisted Medical Device Recalled Due to Software Defect

    The FDA is recalling the VELYS Robotic-Assisted Solution Base due to a software defect in version 1.5.1 related to Daylight Saving Time changes. The defect can cause system errors requiring restart, potentially delaying patient treatment.

    Product
    VELYS Robotic-Assisted Solution Base Product No.: 451570100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2022·2022-05-11

    Estradiol Diagnostic Device Recalled for Falsely Elevated Test Results

    An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2022·2022-05-11

    Estradiol diagnostic test kits recalled for falsely elevated results

    Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.

    Product
    Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2022·2022-05-11

    Restrata Medical Device Recall: Misprinted Expiration Date on Shelf-Box Packaging

    Acera Surgical Inc is recalling 83 units of the Restrata RWM1-2X2 medical device (Lot Number 51745) due to a misprinted expiration date on the shelf-box packaging distributed nationwide.

    Product
    Restrata, Part Number RWM1-2X2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2022·2022-05-11

    Medical Device Software Update Overwrites Custom Antibiotic Codes

    BD Synapsys Microbiology Informatics Software version 4.10 overwrites customer-configured antibiotic codes with BD defaults during system updates, affecting data integrity in clinical microbiology reporting.

    Product
    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2022·2022-05-11

    K-Wire Devices Recalled for Incorrect Length and Diameter Specifications

    Arthrex is recalling 300 K-Wire orthopedic devices that do not meet specified length and diameter requirements. Incorrect dimensions may affect surgical function.

    Product
    K-Wire, 1.35 mm x 170 mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2022·2022-05-11

    Evans Wedge Disposable Trials Orthopedic Surgical Instruments Recalled for Mixed Parts

    restor3d Inc. is recalling Evans Wedge Disposable Trials orthopedic surgical instruments because parts were mixed into other lots during relabeling for extended shelf-life. The recall affects devices distributed nationwide across seven states.

    Product
    Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2022·2022-05-11

    Ultrasonic Gastrovideoscope Recalled Due to Reprocessing Incompatibility and Infection Control Risk

    Olympus recalls the GF-UC140P-AL5 ultrasonic gastrovideoscope nationwide because it is no longer compatible with the OER-Pro reprocessing system, creating an infection control risk to patients.

    Product
    Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2022·2022-05-11

    Evans Wedge Orthopedic Surgical Instrument Recalled for Parts Mixed During Rework

    restor3d Inc. is recalling 9 units of Evans Wedge Disposable Trials orthopedic surgical instruments because parts from different lots were mixed during a manufacturing rework and relabeling process.

    Product
    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2022·2022-05-11

    Medical Diagnostic Test Kit Issues Falsely Elevated Estradiol Results

    Siemens Healthcare is recalling ADVIA Centaur Enhanced Estradiol diagnostic kits because plasma specimens may show falsely elevated results, potentially leading clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2022·2022-05-11

    Cervical Cage Trial Kit Recalled for Incorrect Size Labeling

    restor3d Inc. is recalling 14 units of its Non-Sterile Double Ended Trial Kit because the product was labeled as Small Footprint when it is actually Medium. The lot was distributed nationwide across seven states.

    Product
    Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0953-2022·2022-05-04

    Celltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities

    Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    Distributed nationwide