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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16976–17000 of 40124

  • HighFDA (Devices)·Z-2399-2020·2020-06-24

    Leica ARveo and M530 OH6 Microscope Systems Recalled for Voltage Issues

    Leica Microsystems is recalling ARveo and M530 OH6 microscope systems because voltage changes may cause equipment shutdown, potentially interrupting surgical procedures.

    Product
    Leica ARveo and M530 OH6 microscope systems.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2380-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker GmbH is recalling specific locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2020·2020-06-24

    Stryker Gamma3 End Cap Recalled Due to Compromised Sterility

    Stryker GmbH is recalling specific Gamma3 End Caps because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker GmbH is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2020·2020-06-24

    Abaxis Recalls Piccolo Xpress Chemistry Analyzers Due to Incorrect Reference Ranges

    Abaxis Inc is recalling 15 Piccolo Xpress chemistry analyzers because they display incorrect reference ranges for analytes, which may affect test result interpretation.

    Product
    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2379-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2020·2020-06-24

    Biomet Recalls Screw Instrument Tray Due to Sterilization Validation Failure

    Biomet is recalling 705 units of Screw Instrument Trays because the device and tray failed steam sterilization process validation testing.

    Product
    Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2020·2020-06-24

    Medtronic Bone Void Filler Recalled for Potential Setting Defects

    Medtronic is recalling 6 units of Bone Void Filler, Large, because the product may not maintain its setting characteristics for the labeled shelf-life.

    Product
    Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2381-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker GmbH is recalling specific lots of locking screws because blister pack seals may be compromised, potentially affecting sterility.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2020·2020-06-24

    Medtronic Bone Void Filler Kit Recalled for Setting Defects

    Medtronic is recalling 41 units of Bone Void Filler Kits because the product may not set properly, potentially increasing surgical time and causing incomplete bone formation.

    Product
    Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2394-2020·2020-06-24

    Defibtech Lifeline ECG AEDs Recalled for Potential Shock Delivery Failure

    Defibtech is recalling 860 Lifeline ECG Automated External Defibrillators because a component issue may cause the device to abort or reset, potentially failing to deliver a shock.

    Product
    DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2020·2020-06-24

    Becton Dickinson Recalls Mueller Knife Handles Due to Machining Burr

    Becton Dickinson is voluntarily recalling Mueller Knife Handles because a machining burr on the collet threads may prevent the blade from seating securely.

    Product
    Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2020·2020-06-24

    Biomet Outer Sheath Recalled Due to Failed Sterilization Validation Testing

    Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 because the device and tray failed steam sterilization validation testing.

    Product
    Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2020·2020-06-24

    Biosense Webster PENTARAY NAV Mapping Catheter Recall for Entrapment Risk

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the cardiac valvular apparatus during use.

    Product
    PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2020·2020-06-24

    Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the heart's valves during use.

    Product
    PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2396-2020·2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective Saline Flush Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids. The product is used for in vitro diagnostic testing.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2398-2020·2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Saline Flush Syringes

    AngioDynamics is recalling BioFlo and Xcela PICC kits because they contain BD saline flush syringes that were previously recalled by BD Medical.

    Product
    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2369-2020·2020-06-24

    Resource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects

    Resource Optimization & Innovation LLC is recalling Regard SRHS Central Line Kits because holes in the packaging may compromise the sterile field.

    Product
    Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids compared to expected standards.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2395-2020·2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2366-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier I

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier I units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2402-2020·2020-06-24

    Diasol Recalls Liquid Acid Concentrate for Hemodialysis Due to Labeling Error

    Diasol, Inc. is recalling 212 cases of liquid acid concentrate for hemodialysis because of incorrect labeling of the dialysate concentration.

    Product
    DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2370-2020·2020-06-24

    Abbott Vascular Recalls Xience Sierra Stents Due to Incorrect Expiration Date

    Abbott Vascular is recalling 13 units of Xience Sierra coronary stents because they bear an incorrect expiration date.

    Product
    Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,
    Category
    Medical Device
    Distribution
    Distributed nationwide