The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

22826–22850 of 50430

  • HighFDA (Devices)·Z-2376-2020·2020-06-24

    Stryker End Cap Recall Due to Potential Sterility Compromise

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

    Product
    Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - 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-2374-2020·2020-06-24

    Stryker Compression Screw Recalled Due to Potential Sterility Compromise

    Stryker GmbH is recalling specific Advanced T2 Tibia Compression Screws because the blister pack seal integrity may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - 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-2375-2020·2020-06-24

    Stryker End Cap T2 Tibia Recalled Due to Compromised Sterility

    Stryker GmbH is recalling specific lots of End Cap T2 Tibia implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - 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-2373-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Sterility

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

    Product
    Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - 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-2384-2020·2020-06-24

    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 ¿5x40 mm Catalog Number: 18965040S - 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-2378-2020·2020-06-24

    Stryker Humerus End Cap Recalled for Potential Sterility Compromise

    Stryker GmbH is recalling specific T2 Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - 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-2401-2020·2020-06-24

    Abbott Alinity C Processing Module Recalled for Incorrect Patient Results

    Abbott is recalling 421 Alinity C Processing Modules because they may generate incorrect results for specific chemistry assays.

    Product
    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2386-2020·2020-06-24

    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 ¿5x50 mm Catalog Number: 18965050S - 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-2397-2020·2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective BD Saline Flush Syringes

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

    Product
    BioFlo PICC and Xcela PICC Convenience 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 sampling of blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2020·2020-06-24

    Defibtech DDU-2300 AED Recalled for Potential Shock Delivery Failure

    Defibtech is recalling 860 DDU-2300 AEDs because a component issue may cause the device to abort or fail to deliver a shock.

    Product
    DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2020·2020-06-24

    Stryker Humerus End Cap Recall Due to Compromised Sterility

    Stryker is recalling specific Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - 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-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