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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30126–30150 of 40325

  • ModerateFDA (Devices)·Z-1667-2016·2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1684-2016·2016-05-25

    Zimmer Manufacturing Recalls Trilogy Self-Tapping Bone Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of Trilogy self-tapping bone screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1699-2016·2016-05-25

    FDA Recalls Onset Mixing Pen Due to Missing Use Period Labeling

    Valeant Pharmaceuticals is recalling 7,716 Onset Mixing Pens because the labeling fails to state the 18-month optimal use period from the start of use.

    Product
    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1679-2016·2016-05-25

    Zimmer Manufacturing Recalls Mini MagnaFx Cannulated Bone Screws

    Zimmer Manufacturing B.V. is recalling specific lots of Mini MagnaFx and MagnaFx cannulated bone screws due to a potential small hole in the inner tray of the sterile packaging.

    Product
    Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2016·2016-05-25

    Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.

    Product
    ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2016·2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling 27 Otologic Curved Micro Diamond Ball Burrs because they may be missing the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1687-2016·2016-05-25

    Diamedix IgG Test Kits Recalled Due to Gel-Like Substance in Diluent

    Diamedix Corporation is recalling 94 Is-EBV-EA-D and Is-Mumps IgG Test Kits because a gel-like substance was found in the sample diluent, potentially compromising performance.

    Product
    Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2016·2016-05-25

    Diamedix Is-Mumps IgG Test Kit Recalled Due to Sample Diluent Contamination

    Diamedix Corporation is recalling 697 Is-Mumps IgG Test Kits because a gel-like substance was found in the sample diluent, which could compromise product performance.

    Product
    Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2016·2016-05-25

    Diamedix IgG Test Kits Recalled Due to Sample Diluent Contamination

    Diamedix Corporation is recalling 588 EBV-VCA and Mumps IgG test kits because a gel-like substance in the sample diluent could compromise performance.

    Product
    Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2016·2016-05-25

    Zimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole

    Zimmer Manufacturing B.V. is recalling specific lots of 2.7 mm Cortical Screws because a small hole may be present in the inner tray of the sterile packaging.

    Product
    Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2016·2016-05-25

    Zimmer Manufacturing Recalls Hip and Trauma Implant Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2016·2016-05-25

    Zimmer Universal Locking System Cortical Screws Recalled for Packaging Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.

    Product
    Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1670-2016·2016-05-25

    Siemens ADVIA Chemistry Triglyceride Reagent Recalled for Linearity Defects

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglyceride reagent lots 348297 and 359932 because they fail linearity claims near end of shelf life.

    Product
    ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1646-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1637-2016·2016-05-18

    Bradshaw Medical Recalls Axial Torque Limiting Drivers Due to Component Failure

    Bradshaw Medical Inc. is recalling 3,760 Axial Torque Limiting Drivers because a component failure could cause applied torque to exceed the calibrated setting.

    Product
    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error

    Biomerieux is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1645-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1632-2016·2016-05-18

    St. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk

    St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.

    Product
    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1634-2016·2016-05-18

    Stryker Recalls CinchLock SS Knotless Anchor Due to Wire Breakage

    Stryker is recalling CinchLock SS Knotless Anchors after reports of internal wire breakage upon deployment.

    Product
    CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1640-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1648-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1642-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states