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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24051–24075 of 40175

  • HighFDA (Devices)·Z-1504-2018·2018-05-02

    Stryker Recalls T4 Pullover Toga Due to Material Separation Risk

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a potential risk of exposure to contaminants.

    Product
    T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2018·2018-05-02

    Stryker T4 Pullover Toga Recall Due to Layer Separation Risk

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2018·2018-05-02

    Integra LifeSciences Recalls Humeral Stem Trials for Breakage Risk

    Integra LifeSciences is recalling 1,619 humeral stem trials for the Titan Modular Shoulder System because they may break during surgery.

    Product
    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2018·2018-05-02

    Stryker T4 Pullover Toga Recall Due to Layer Separation

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wire Ball Tips Due to Packaging Seal Failure

    Zimmer Biomet is recalling Humeral Guide Wire Ball Tips because the sterile packaging seal may fail, potentially compromising the device's sterility.

    Product
    Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2018·2018-05-02

    BD Vacutainer Blood Collection Set Recalled for Sterility Assurance Failure

    Becton Dickinson is recalling BD Vacutainer Ultra Touch Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.

    Product
    BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2018·2018-05-02

    Terumo Flowmeter Module Recalled for Inaccurate Flow Readings

    Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Modules for the Advanced Perfusion System 1 due to inaccurate flow readings that may be difficult to detect.

    Product
    Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1522-2018·2018-05-02

    Zimmer Biomet Recalls Orthopedic Salvage System Locking Collars

    Zimmer Biomet is recalling Orthopedic Salvage System locking collars due to a potential dry blast irregularity on the screws.

    Product
    Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1475-2018·2018-05-02

    Zimmer Biomet Recalls Intramedullary Fixation Guide Wires Due to Packaging Seal Failure

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2018·2018-05-02

    Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch

    Zimmer GmbH is recalling Avenir Muller Stems due to a potential commingle that could result in the product not matching the outer label.

    Product
    Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1497-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 19 MicroVue CIC-C1q EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2018·2018-05-02

    Smith & Nephew Whipknot Sutures Recalled for Sterile Barrier Defect

    Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because packaging design flaws may allow sterile barrier breaches.

    Product
    Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1524-2018·2018-05-02

    Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch

    Zimmer GmbH is recalling specific Avenir Muller Stem implants because a potential commingle may cause the product in the package to not match the outer label.

    Product
    Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1467-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to potential sterile packaging seal failures.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1496-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Validation Concerns

    Diagnostic Hybrids, Inc. is recalling 101 MicroVue CIC-C1q EIA kits because the standard curve slope may fail validation requirements.

    Product
    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1534-2018·2018-05-02

    Ethicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error

    Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.

    Product
    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1526-2018·2018-05-02

    Stryker Recalls 18 Hinge Coupling Units Due to Packaging Error

    Stryker GmbH is recalling 18 Hinge Coupling Hoffmann LRF units because connecting nuts were incorrectly packed in hinge coupling packaging.

    Product
    Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1499-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 72 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1512-2018·2018-05-02

    Howmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling

    Howmedica Osteonics Corp. is recalling six sterile knee prosthesis units because the implant size may not match the box label.

    Product
    Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1529-2018·2018-05-02

    Accelerate PhenoTest BC kit recalled for false positive results

    Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.

    Product
    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1519-2018·2018-05-02

    Roche Acetaminophen Assay Method Sheets Missing Interference Statement

    Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.

    Product
    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1521-2018·2018-05-02

    Cook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error

    Cook Inc. is recalling 40 Advance 35LP Low-Profile PTA Balloon Dilatation Catheters because some units were packaged with incorrect size labels.

    Product
    Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1474-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterile Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because of a potential failure of the sterile packaging seal.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
    Category
    Medical Device
    Distribution
    Distributed nationwide