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 deaths or serious injuries are reported, 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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13651–13675 of 13802

  • HighFDA (Devices)·Z-1826-2021·2021-06-16

    Atec Insignia Cervical Plate Screw Locking Mechanism May Fail

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism that could cause separation during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2021·2021-06-16

    Alphatec Insignia Cervical Plate System Screw Locking Mechanism May Disassociate or Unlock

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2021·2021-06-16

    WishBone Medical Plate and Screw System Engineering Specification Nonconformity Recall

    Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.

    Product
    WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1837-2021·2021-06-16

    Sunstar G.U.M Perioshield Oral Rinse Recalled Due to Bacterial Contamination

    Sunstar Americas is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse 300mL (SKU 1775P, 1775R) due to potential contamination with Burkholderia bacteria.

    Product
    SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2021·2021-06-16

    Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2021·2021-06-16

    Myriad-LX Light Source Recalled Due to Burn and Occlusion Risk

    Nico Corp. is recalling 80 Myriad-LX Light Source units due to potential burn injury to patients from the distal tip of the fiber assembly and risk of delivery sleeve occlusion during surgical use.

    Product
    Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2021·2021-06-16

    Anterior Cervical Plate System Recalled for Screw Locking Failure

    Alphatec Spine is recalling its Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism during or after surgery that could compromise implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1845-2021·2021-06-16

    DePuy Synthes Hip Prosthesis Recall Due to Incorrect Size Labeling

    DePuy Orthopaedics recalled 50 hip prostheses with incorrect part numbers and sizes etched on the devices. The affected Lot D20111130 was distributed domestically and to Bermuda.

    Product
    DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1809-2021·2021-06-16

    Anterior cervical plate system screw blocking mechanism may disassociate

    Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2021·2021-06-16

    Cervical Plate System screw locking mechanism may fail during or after surgery

    Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2021·2021-06-16

    Medical Device Illumination Pack Recalled Due to Burn and Occlusion Risks

    Nico Corp. is recalling 439 NICO Myriad-LX Illumination Packs used in surgical procedures due to potential delivery sleeve occlusion and thermal burn injury from the fiber tip assembly.

    Product
    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

    Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System screw failure recalled

    Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2021·2021-06-16

    Anterior cervical plate system screw blocking mechanism defect recalled

    Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Screw Blocking Mechanism Risk

    The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recalled for Potential Screw Failure

    Alphatec Spine recalled the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism, which could disassociate during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2021·2021-06-16

    Anterior cervical plate system screw mechanism may disassociate or unlock

    The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2021·2021-06-16

    Anterior Cervical Plate System Screw Lock Mechanism May Fail Intraoperatively or Postoperatively

    The Alphatec Insignia Anterior Cervical Plate System is recalled because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. Eight units were distributed across 15 U.S. states.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2021·2021-06-16

    Anterior cervical plate system may lose screw locking mechanism during surgery

    Alphatec Spine's Insignia Anterior Cervical Plate System may have a defective screw blocking mechanism that could disassociate during or after surgery. The FDA has recalled 19 units distributed across 15 US states.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Blocking Mechanism Disassociation Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2021·2021-06-16

    CooperSurgical Wallach Loop Electrode recalled for incorrect packaging

    CooperSurgical has recalled its Wallach Loop Electrodes (Lot 274420) due to incorrect packaging. Packages labeled as Square Electrodes contained Round Electrodes instead, creating a risk of improper device use in surgical procedures.

    Product
    CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1844-2021·2021-06-16

    Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise

    Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.

    Product
    Quanta System Sterile Optical Laser Fiber, reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Mechanism Failure Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during surgery or unlock afterward. Eight units were distributed across 15 states.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
    Category
    Medical Device
    Distribution
    Distributed nationwide