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 the agency’s own highest classification or reported deaths or serious injuries, 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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22751–22775 of 40299

  • ModerateFDA (Devices)·Z-2900-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2945-2018·2018-09-05

    Ceterix Disposable Knot Pusher Recalled for High Cut Force

    Ceterix Orthopedics is recalling 96 units of the Disposable Knot Pusher / Suture Cutter because nonconforming blades may require higher than specified cut force.

    Product
    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2911-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2907-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2899-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2902-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2944-2018·2018-09-05

    Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk

    Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.

    Product
    Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2914-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2898-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Pack Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2912-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2843-2018·2018-08-29

    Philips DigitalDiagnost 4.1 Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4.1 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to operators and patients.

    Product
    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2895-2018·2018-08-29

    Philips SureSigns Patient Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VM, VS, and VSV patient monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2848-2018·2018-08-29

    Philips DigitalDiagnost 2.x Upgrades Recalled Due to Footplate Safety Hazard

    Philips is recalling DigitalDiagnost 2.x Upgrades because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2892-2018·2018-08-29

    Philips SureSigns VSV Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VSV monitors because lithium-ion batteries may overheat or ignite if not replaced on schedule, posing fire and injury risks.

    Product
    Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2837-2018·2018-08-29

    Siemens 3D TOP Ceiling Stand Recalled for Potential Rope Failure

    Siemens Medical Solutions is recalling 699 3D TOP Ceiling Stands because a load-bearing rope could break, causing the arm to drop and potentially seriously injure patients or users.

    Product
    3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2817-2018·2018-08-29

    bioMerieux VITEK 2 Gram Positive Test Kits Recalled for MRSA Detection Issues

    bioMerieux is recalling VITEK 2 Gram Positive Test Kits because customer reports indicated an increased rate of non-detected MRSA.

    Product
    bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2896-2018·2018-08-29

    Philips SureSigns VS2 Monitor Recall for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VS2 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2894-2018·2018-08-29

    Philips SureSigns VS4 Vital Signs Monitor Recalled for Battery Fire Risk

    Philips is recalling SureSigns VS4 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2893-2018·2018-08-29

    Philips SureSigns VS3 Vital Signs Monitor Recall for Battery Fire Risk

    Philips is recalling SureSigns VS3 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2838-2018·2018-08-29

    Siemens 3D V Ceiling Stand Recalled for Potential Rope Failure

    Siemens is recalling 3D V ceiling stands because the primary load-bearing rope could break, causing the arm to drop and potentially seriously injuring patients or users.

    Product
    3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2753-2018·2018-08-29

    Handicare P600 Series Patient Lift Recalled for Strap Wear and Breakage

    Handicare USA Inc. is recalling four P600 Series patient lifts due to premature strap wear and breakage at maximum weight conditions.

    Product
    Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2860-2018·2018-08-29

    Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost Rel.4 Upgrades because a defective hook may allow the footplate to fall or swing, potentially injuring patients or operators.

    Product
    DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2844-2018·2018-08-29

    Philips DigitalDiagnost Release 3 Footplate Hook Recall

    Philips is recalling DigitalDiagnost Release 3 units because a defective hook may allow the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Release 3 (Stitching Patient Support) 712025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2741-2018·2018-08-29

    Compass Health Brands Recalls CPAP Mask Cushions Due to Design Incompatibility

    Compass Health Brands is recalling CPAP mask cushions because a design change makes them incompatible with previous elbow parts, potentially causing unacceptable CO2 porting.

    Product
    CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every…
    Category
    Medical Device
    Distribution
    Distributed nationwide