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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13651–13675 of 27471

  • HighFDA (Devices)·Z-2133-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2057-2020·2020-06-03

    Heartware HVAD Pump Implant Kit Recalled for Graft and Screw Defects

    Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2135-2020·2020-06-03

    MOTek Medical Recalls Body Weight Support Light Due to Yoke Detachment Risk

    MOTek Medical is recalling 80 units of the Body Weight Support Light (Model RB011) because a manufacturing deviation may cause the yoke to detach from the cable guide.

    Product
    Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets

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

    Product
    Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2149-2020·2020-06-03

    Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels

    Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2020·2020-06-03

    Biomet Recalls Shoulder Implant Components Due to Endotoxin Levels

    Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.

    Product
    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health Inc. 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 Set, Anti-free Flow, Product Code 775659
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2152-2020·2020-06-03

    Biomet Recalls Vanguard Knee System Bearings Due to Endotoxin Levels

    Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2020·2020-06-03

    Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels

    Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2020·2020-06-03

    Abbott Recalls Architect iGentamicin Reagent Kits Due to Assay Interaction

    Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.

    Product
    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2020·2020-06-03

    Greiner VACUETTE Blood Transfer Units Recalled for Needle Dislodgement Risk

    C.A. Greiner & Sohne Gesellschaftmbh is recalling VACUETTE Blood Transfer Units because needles may dislodge during use, posing a risk of needle stick injury or blood leakage.

    Product
    VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2151-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specification limits.

    Product
    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2020·2020-06-03

    Argon Skater Introducer Set Recalled Due to Detaching Tungsten Coils

    Argon Medical Devices is recalling Skater Introducer Sets because tungsten coils on the guidewire may detach. The recall affects 15,795 units distributed in China and Taiwan.

    Product
    Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2039-2020·2020-06-03

    Medtronic Confida Expandable Sheath Recalled for Vascular Complication Risk

    Medtronic is recalling 103 units of the Confida Expandable Sheath due to an increased risk of vascular complications, including bleeding, hematoma, and dissection.

    Product
    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2163-2020·2020-06-03

    Hologic Panther Fusion Extraction Reagent-S Recalled for False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-S kits because a reagent component may cause false positive or negative flu test results, potentially delaying treatment.

    Product
    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2110-2020·2020-06-03

    Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error

    The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.

    Product
    Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-2022-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2017-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Size 24x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2060-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Open Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Open Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2015-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2009-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2010-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90111, UDI # 10888857108240, Size 24x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide