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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18976–19000 of 40124

  • ModerateFDA (Devices)·Z-0382-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 3.2 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0377-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometric Design Defect

    Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0364-2020·2019-11-20

    Implant Direct Recalls Dental Implants Due to Packaging Error

    Implant Direct is recalling 23 dental implants because a QA inspection found a healing collar was packaged instead of the implant.

    Product
    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0393-2020·2019-11-20

    Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0398-2020·2019-11-20

    Orthofix Recalls Lower Limb Diaphyseal Sterile Kits Due to Drill Bit Design

    Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0386-2020·2019-11-20

    Orthofix Radiolucent Wrist Fixator Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Radiolucent Wrist Fixator Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0349-2020·2019-11-20

    Synthes Trial Spacers Recalled for Modified Manufacturing Process

    Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.

    Product
    MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0363-2020·2019-11-20

    Implant Direct Dental Implants Recalled for Potential Packaging Error

    Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.

    Product
    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0399-2020·2019-11-20

    Orthofix Recalls Tibia Femur Diaphyseal Sterile Kits Due to Design Defect

    Orthofix Srl is recalling Tibia Femur Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0374-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0401-2020·2019-11-20

    Orthofix Ankle Transfix Pin Sterile Kit Recalled for Design Defect

    Orthofix Srl is recalling Ankle Transfix Pin Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0388-2020·2019-11-20

    Orthofix Recalls XCaliber Ankle Kits Due to Drill Bit Design Defect

    Orthofix is recalling XCaliber Ankle Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0361-2020·2019-11-20

    Exactech Recalls Fluted Pin Pouches Due to Potential Quantity Error

    Exactech is recalling 2.4mm x 2.5 Fluted Pin Pouches because they may contain one pin instead of four. The recall covers 9 units distributed in four states.

    Product
    2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Diaphyseal Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0362-2020·2019-11-20

    Tec Com TECOTHERM NEO Thermo-Regulation System Recalled for Faulty Peltier Elements

    Tec Com GmbH is recalling five TECOTHERM NEO thermo-regulation systems due to faulty Peltier elements that may fail to maintain temperature control.

    Product
    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0373-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0383-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometric Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometric detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0391-2020·2019-11-20

    Orthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect

    Orthofix is recalling Prefix II Diaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0397-2020·2019-11-20

    Orthofix Recalls Lower Limb Diaphyseal Sterile Kits Due to Drill Bit Design

    Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0376-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Deviation

    Orthofix Srl is recalling specific batches of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0385-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0395-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix is recalling Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0389-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw

    Orthofix Srl is recalling UE Xcaliber Ankle Complete Kits because drill bits have a design flaw that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0375-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0358-2020·2019-11-20

    TriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard

    TriMed Inc. is recalling 1,903 Peg Guide Extenders because the spring can rust due to the steel used. The product was distributed nationwide and to several foreign countries.

    Product
    TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide