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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13601–13625 of 27500

  • SevereFDA (Devices)·Z-2107-2020·2020-06-03

    MPS Top Cover Replacement Kit Recalled Due to Swapped Labels

    Quest Medical is recalling MPS Top Cover Replacement Kits because additive and arrest agent labels were swapped, posing a risk of over-delivering potassium during surgery.

    Product
    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2146-2020·2020-06-03

    Biomet Recalls Regenerex Knee Prostheses Due to Potential Endotoxin Levels

    Biomet is recalling 15 units of Regenerex Series-A Patella knee prostheses due to potential endotoxin levels exceeding specifications.

    Product
    Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2118-2020·2020-06-03

    Clinical Innovations Recalls Clearview Total Uterine Manipulator Due to Defective Tip Support

    Clinical Innovations is recalling 280 Clearview Total Uterine Manipulators (model UM750) because a missing notch on the tip support may prevent proper attachment of surgical components.

    Product
    Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2128-2020·2020-06-03

    Siemens Cios Spin X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 20 Cios Spin X-Ray systems because unplugging the monitor cable can create unsafe voltage, posing an electrical shock hazard.

    Product
    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2056-2020·2020-06-03

    Heartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage

    Heartware, Inc. is recalling 2,225 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2126-2020·2020-06-03

    Thermo Fisher Recalls Non-Sterile Bio-Tite Specimen Containers

    Thermo Fisher Scientific is recalling 78,600 Bio-Tite specimen containers that were not irradiated and are not sterile.

    Product
    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2150-2020·2020-06-03

    Biomet Recalls Vanguard Knee System Tibial Bearings Due to Endotoxin Levels

    Biomet, Inc. is recalling 46 units of Vanguard Knee System tibial bearings because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2020·2020-06-03

    Philips Recalls Sterilizable Defibrillator Internal Paddles Due to Wear Risk

    Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.

    Product
    Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2020·2020-06-03

    Nikon Metrology XTH Cabinet X-Ray Systems Recalled for Shielding Defect

    Nikon Metrology is recalling 110 XTH cabinet x-ray systems because interior shielding may detach, potentially causing x-ray emissions to exceed safety limits.

    Product
    Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Epump Safety Screw Spike sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2158-2020·2020-06-03

    Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Epix latis GRASPER devices because a protruding rivet may cause tissue damage during use.

    Product
    Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2131-2020·2020-06-03

    Intuitive Surgical Recalls da Vinci SP Cameras Due to Residual Soil

    Intuitive Surgical is recalling 305 da Vinci SP cameras because residual soil on the tip may affect image quality or cause patient sensitization.

    Product
    da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2020·2020-06-03

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 260 HeartStart MRx Monitor/Defibrillators because some units may not have received required corrections from prior field actions.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2020·2020-06-03

    Biomet Recalls Vanguard M Partial Knee System MonoBlock Tibial Trays

    Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays due to potential elevated endotoxin levels.

    Product
    Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Safety Switch Delay

    Inpeco S.A. is recalling two Accelerator a3600 Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

    Product
    Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2161-2020·2020-06-03

    Applied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.

    Product
    Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2153-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.

    Product
    Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2020·2020-06-03

    Philips HeartStart XL Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.

    Product
    Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2020·2020-06-03

    Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels

    Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.

    Product
    Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Delayed Safety Switch Activation

    Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

    Product
    FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290)…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2102-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Connect ENPlus Spike Sets for Leaking

    Cardinal Health is recalling Kangaroo Connect ENPlus Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2143-2020·2020-06-03

    Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk

    Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.

    Product
    Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2020·2020-06-03

    Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels

    Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2020·2020-06-03

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures

    Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.

    Product
    ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide