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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25076–25100 of 40357

  • ModerateFDA (Devices)·Z-0600-2018·2018-02-21

    ConforMIS Recalls Mislabeled Total Knee Replacement Implant Kits

    ConforMIS, Inc. is recalling two total knee replacement kits due to mislabeling. The affected units were distributed in California and Texas.

    Product
    Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0608-2018·2018-02-21

    Keystone Dental Recalls Multi-Unit Abutments Due to Screw Fit Issues

    Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.

    Product
    Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0605-2018·2018-02-21

    Beckman Coulter Recalls Unpaired Lyophilized Chemistry Calibrator Lots

    Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.

    Product
    Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based…
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-0620-2018·2018-02-21

    Aesculap ELAN 4 Drill Accessories Recalled for Lack of FDA Clearance

    Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.

    Product
    ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0606-2018·2018-02-21

    Gibson Laboratories Recalls Blastomyces Antiserum Due to False Positives

    Gibson Laboratories LLC is recalling Blastomyces dermatitidis Antiserum vials because the product was reporting false positive results.

    Product
    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0621-2018·2018-02-21

    Aesculap ELAN 4 Burr and Blade Accessories Recalled for Regulatory Violation

    Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories because they were marketed without 510(k) premarket notification clearance.

    Product
    ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0602-2018·2018-02-21

    Arrow PICC Catheter Recall Due to Incorrect Component Kits

    Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.

    Product
    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2018·2018-02-21

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Missing Components

    Synthes (USA) Products LLC is recalling 4 units of sterile titanium trochanteric fixation nails because the locking mechanism and protective cap were missing.

    Product
    11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0632-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues

    Cook Inc. is recalling 75 central venous catheter sets because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0575-2018·2018-02-21

    B. Braun Recalls Pain Management Trays with Foreign Matter

    B. Braun Medical is recalling 460 Pain Management Trays containing 22GA SafetyGlide Needles due to the presence of loose polypropylene foreign matter.

    Product
    Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2018·2018-02-21

    Aesculap ELAN 4 Air System Recalled for Premarket Clearance Issues

    Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.

    Product
    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2018·2018-02-21

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Fit Issues

    Cook Inc. is recalling 304 Spectrum Central Venous Catheter Trays because the catheters may not fit over the guide wire, potentially causing procedure delays.

    Product
    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2018·2018-02-21

    Arrow Radial Artery Catheterization Set Recalled for Foreign Matter

    Arrow International Inc is recalling Radial Artery Catheterization Sets due to the presence of loose polypropylene foreign matter above release specifications.

    Product
    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0562-2018·2018-02-21

    Philips Ingenuity TF PET/CT Software Recall for Reconstruction Failures

    Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.

    Product
    Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0567-2018·2018-02-21

    B. Braun Recalls Perifix Anesthesia Kits Due to Foreign Matter

    B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.

    Product
    Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0574-2018·2018-02-21

    B. Braun Recalls Epidural Anesthesia Kits Due to Foreign Matter

    B. Braun Medical is recalling 120 units of Customer Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.

    Product
    Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2018·2018-02-21

    Pentax Video Cystoscopes Recalled for Lack of FDA Clearance

    Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.

    Product
    Video Cystoscope models ECY-1570 and ECY-1570K
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0633-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheters Due to Fit Issues

    Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2018·2018-02-21

    Zimmer Surgical Recalls A.T.S. 2200TS Tourniquet Systems for Labeling Updates

    Zimmer Surgical is recalling 8,231 A.T.S. 2200TS Tourniquet Systems to update on-device labels and operator manuals regarding RF communication equipment separation distances.

    Product
    A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0576-2018·2018-02-21

    B. Braun Recalls Contiplex Nerve Block Trays Due to Foreign Matter

    B. Braun Medical is recalling 300 Contiplex Nerve Block Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0616-2018·2018-02-21

    AMEDA Recalls Purely Yours Breast Pumps Due to Incorrect Power Adapter

    AMEDA is recalling specific lots of Purely Yours Breast Pumps because they were manufactured with a UK power adapter instead of the correct one.

    Product
    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
    Category
    Medical Device
    Distribution
    14 states