The Recall Desk

Hazard

Device Incompatibility recalls

19 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
19
Critical
1
Severe
7
Most recent
2024-11-20

Of the 19 device incompatibility recalls we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (37%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device incompatibility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–19 of 19

  • CriticalFDA (Devices)·Z-0310-2025·2024-11-20

    Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors

    Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.

    Product
    Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2024·2024-02-28

    PERIFIX epidural kits recalled for incompatible filter straw connectors

    B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.

    Product
    Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0847-2024·2024-02-14

    Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.

    Product
    Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0848-2024·2024-02-14

    Enteral Syringes Recalled for Incompatibility with Feeding Pumps

    Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0850-2024·2024-02-14

    Cardinal Health Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2024·2023-11-01

    Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.

    Product
    Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2023·2023-07-26

    Impella LD cardiac pump recalled for impeller damage and embolization risk

    Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.

    Product
    Impella LD intravascular micro axial blood pump, Product Number 005082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2023·2023-05-17

    Bard Mission Biopsy Instrument Kit cannula and needle incompatibility

    Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2023·2023-04-05

    CoCr Femoral Head hip implant compatibility removed due to motion limitations

    Zimmer is updating the compatibility matrix for the CoCr Femoral Head XS hip implant to remove pairing with Epsilon Durasul Constrained Acetabular Liners due to insufficient range of motion in flexion/extension.

    Product
    CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1260-2023·2023-03-22

    Bard Mission Disposable Core Biopsy Instrument Kit Recall: Sizing Incompatibility

    Bard Peripheral Vascular is recalling certain Bard Mission Disposable Core Biopsy Instrument Kits due to sizing incompatibility between the biopsy instrument and coaxial needle, which could cause procedural delays or needle breakage.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2023·2022-12-21

    NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates

    Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.

    Product
    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2023·2022-10-19

    COVID Test Kits Recalled for Incorrect Labeling and Device Incompatibility

    American Contract Systems is recalling COVID test kits incorrectly labeled for SARS-CoV-2 testing use. The 39,575 kits distributed in Pennsylvania should not be used with COVID devices.

    Product
    COVID Test Kit Nonsterile
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1778-2022·2022-10-05

    Incompatible tibial bearing supplied for knee prosthesis installation

    An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.

    Product
    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2597-2016·2016-08-31

    Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk

    Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1694-2015·2015-06-10

    Zimmer Recalls 4.5mm Cortical Screws for M/DN Intramedullary Nail System

    Zimmer, Inc. is recalling 4.5mm Cortical Screws for the M/DN system because they are not compatible with the device, potentially causing surgical complications.

    Product
    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0583-2015·2014-12-31

    Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0587-2015·2014-12-31

    Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper device operation.

    Product
    ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2015·2014-12-31

    Heart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility

    Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper use.

    Product
    ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2015·2014-12-31

    Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult/Child Radiotransparent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single
    Category
    Medical Device
    Distribution
    Distributed nationwide