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.

Filters

Agency

Category

Minimum severity

Clear filters

23626–23650 of 40175

  • HighFDA (Devices)·Z-1927-2018·2018-05-30

    Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms

    Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.

    Product
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1921-2018·2018-05-30

    Smith & Nephew Recalls Anthology Hip Stems Due to Manufacturing Defect

    Smith & Nephew is recalling 13 units of Anthology hip prosthesis stems because they were manufactured with an undersized taper length.

    Product
    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2018·2018-05-30

    Synthes Torque Limiting Handle Recalled Due to Premature Rusting

    Synthes (USA) Products LLC is recalling 50 Torque Limiting Handles because high-carbon ball bearings may rust prematurely, causing functional degradation.

    Product
    Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2018·2018-05-30

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak

    Edwards Lifesciences is recalling 3,052 IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end of the strain relief.

    Product
    Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1896-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Product
    First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1930-2018·2018-05-30

    Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue

    Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.

    Product
    Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1898-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Product
    First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1917-2018·2018-05-30

    Implant Direct Dental Implants Recalled for Incorrect Cap Labeling

    Implant Direct Sybron Manufacturing is recalling 298 dental implants because the vial cap may display an incorrect part number, though the main label is correct.

    Product
    ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2018·2018-05-30

    Smith & Nephew Recalls Genesis II Knee Bushings Due to Labeling Error

    Smith & Nephew is recalling 18 units of Genesis II knee bushings because the left and right sides were incorrectly laser marked.

    Product
    smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1904-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 16 units of Legion CR XLPE Articular Inserts because the inner packaging pouch was inadvertently sealed with the outer pouch.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1926-2018·2018-05-30

    Baxter Recalls Prismaflex 7.20 US Control Units for Firmware Update

    Baxter Healthcare is recalling 231 Prismaflex 7.20 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1909-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1923-2018·2018-05-30

    Baxter Prismaflex 5.10 US Control Units Recalled for Firmware Update

    Baxter Healthcare is recalling 1,256 Prismaflex 5.10 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1894-2018·2018-05-30

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects

    Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.

    Product
    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1908-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1897-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Kits Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Kits due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1900-2018·2018-05-30

    Madison Polymeric Engineering Recalls Draco Enzymatic Deep-Cleaning Pads

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1910-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1919-2018·2018-05-30

    LivaNova Inspire 8 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 70 units of Inspire 8 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1924-2018·2018-05-30

    Baxter Prismaflex Control Units Recalled for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex control units to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1911-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1922-2018·2018-05-30

    Baxter Recalls Prismaflex Systems for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex Systems to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1925-2018·2018-05-30

    Baxter Recalls Prismaflex Control Units for Firmware Update

    Baxter Healthcare is recalling 557 Prismaflex 7.XX US control units worldwide to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1912-2018·2018-05-30

    Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices

    Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.

    Product
    AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at…
    Category
    Medical Device
    Distribution
    5 states