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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23701–23725 of 40299

  • ModerateFDA (Devices)·Z-1933-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2018·2018-06-06

    Arrow International Recalls CVC Kits Due to Unsealed Packaging

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1972-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling specific central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2018·2018-05-30

    LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination

    LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.

    Product
    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
    Category
    Medical Device
    Distribution
    44 states
  • 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