The Recall Desk

Hazard

Therapy Delay recalls

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

What the numbers show

Total
29
Critical
0
Severe
2
Most recent
2025-05-28

Of the 29 therapy delay recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (7%) 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 therapy delay 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.

1–25 of 29

  • HighFDA (Devices)·Z-1808-2025·2025-05-28

    BD Cathena Safety IV Catheter manufacturing defect hole septum

    Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.

    Product
    BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3179-2024·2024-09-25

    B Braun Streamline Bloodline Set Recalled for Potential Occlusion

    B Braun Medical Inc. is recalling Streamline Bloodline Sets because incomplete connector insertion may cause flow restrictions during hemodialysis.

    Product
    STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled Due to Monoject Syringe Incompatibility

    B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or therapy delays.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2436-2024·2024-07-31

    Perfusor Space infusion pump syringe incompatibility may cause dosing error

    B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2024·2024-07-31

    Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility

    B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1484-2024·2024-04-17

    Ivenix Infusion System Software Recalled for Potential Dosing Anomalies

    Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.

    Product
    LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1283-2024·2024-03-20

    Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions

    Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.

    Product
    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2024·2024-03-20

    Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay

    Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.

    Product
    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2024·2024-03-06

    Infusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction

    Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.

    Product
    Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2024·2023-11-15

    Medical administration set for radiation therapy recalled due to leakage risk

    B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

    Product
    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0128-2024·2023-11-15

    B. Braun FT1000S Fluid Transfer Sets may leak, risking infection

    B. Braun is recalling FT1000S Fluid Transfer Sets due to a manufacturing defect that may cause leakage. This could delay therapy, increase infection risk, and expose healthcare workers to hazardous medication.

    Product
    FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1217-2023·2023-03-15

    Heartsine Samaritan PAD defibrillators distributed with incorrect language configuration

    Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.

    Product
    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0131-2023·2022-11-02

    LINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling

    Datascope's LINEAR intra-aortic balloon catheter has an incorrect balloon volume label on internal instructions that may delay critical therapy in unstable patients.

    Product
    LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2464-2021·2021-09-22

    Needle-Free Burette Set Valves Recalled for Occlusion and Flow Issues

    BD ADD-ON Burette Set V/NV Needle-Free Valves may experience occlusions or flow issues that could delay therapy. CAREFUSION recalled 44,120 units with this defect.

    Product
    BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2021·2021-09-22

    BD SmartSite Needle-Free Connector Valves Recalled for Flow and Occlusion Issues

    CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.

    Product
    BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2021·2021-09-22

    BD SmartSite Bag Access Device Recalled for Valve Occlusion Issues

    CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.

    Product
    BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2021·2021-09-22

    BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues

    CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.

    Product
    BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2459-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues

    BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.

    Product
    BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2463-2021·2021-09-22

    BD Gravity IV needle-free connector valve occlusion risk

    BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.

    Product
    BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & Smar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2021·2021-09-22

    BD SE Burette Set needle-free connectors recalled for flow obstruction risk

    CareFusion is recalling BD SE Burette Sets with needle-free connector valves that may fail to flush or develop flow obstructions, risking therapy delays. Approximately 56,680 units were distributed worldwide.

    Product
    BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues

    BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.

    Product
    BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2021·2021-09-15

    Philips HEARTSTART Infant/Child Defibrillator Pads Recalled for Incorrect Labeling

    Philips infant/child defibrillator pads are recalled due to incorrect labeling that could delay therapy or result in lower energy delivery than indicated.

    Product
    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2794-2020·2020-08-19

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

    Product
    Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel tra
    Category
    Medical Device
    Distribution
    0 states