The Recall Desk

Hazard

Treatment Delay recalls

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

What the numbers show

Total
90
Critical
0
Severe
14
Most recent
2026-05-06

Of the 90 treatment 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 14 (16%) 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 treatment 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.

26–50 of 90

  • HighFDA (Devices)·Z-1340-2025·2025-03-26

    General Angio Pack Sterilization Assurance Cannot Be Confirmed

    American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.

    Product
    GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2025·2025-03-26

    Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk

    Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2025·2025-03-26

    Neuro IR Tray recalled over unconfirmed sterilization assurance

    American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.

    Product
    NEURO IR TRAY , Model No WENI56J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2025·2025-01-22

    Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results

    Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.

    Product
    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-3139-2024·2024-09-25

    Alaris PCA Pump Module May Have Defective IUI Connector

    CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3138-2024·2024-09-25

    Infusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector

    CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.

    Product
    Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3142-2024·2024-09-25

    Alaris Pump Module 8100 Recalled for Bent Connector That May Disable Device

    CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.

    Product
    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk

    B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2024·2024-07-24

    Blood collection tubes recalled for missing additive and separation failures

    Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.

    Product
    VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2024·2024-07-03

    FDA Recalls CUSA Excel Surgical Handpiece for Housing Cracks

    Integra LifeSciences is recalling CUSA Excel C2600 surgical handpieces due to potential housing cracks that may delay treatment. The recall affects 2,652 units distributed nationwide and internationally.

    Product
    CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2024·2024-06-12

    Alaris Pump Infusion Set Drip Chamber May Detach During Use

    A defective drip chamber in the Alaris Pump Infusion Set may detach from the tubing, potentially delaying treatment or causing unintended exposure to medications. BD is recalling approximately 11,300 units distributed across the US and Canada.

    Product
    Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2024·2024-06-05

    Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery

    Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2024·2024-06-05

    Mako 3.0 and 3.1 surgical systems software error causes treatment delays

    Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without system restart.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2024·2024-06-05

    Stryker Mako Surgical Robot Software Error Causes Treatment Delays

    Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2024·2024-06-05

    Mako robotic surgery system software error causes treatment delays

    Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2024·2024-05-01

    Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage

    The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.

    Product
    Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2024·2024-01-17

    Diagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue

    BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0417-2024·2023-12-06

    Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk

    Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.

    Product
    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0359-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings

    Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0358-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors

    The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2651-2023·2023-10-11

    Cuff Pressure Manager Power Inlet Dislodgment Prevents Charging

    The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.

    Product
    Puritan Bennett Cuff Pressure Manager, REF: 180-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2625-2023·2023-09-27

    Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

    Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-2369-2023·2023-08-23

    Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk

    Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2384-2023·2023-08-23

    Dialysis catheters recalled for potential center lumen obstruction

    Covidien LP is recalling MAHURKAR dialysis catheters because excessive silicone lubricant coats the center lumen, potentially blocking blood flow or creating clots and other blood vessel complications.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2367-2023·2023-08-23

    Covidien MAHURKAR Dialysis Catheter Recalled for Lumen Occlusion Risk

    Covidien is recalling dialysis catheters with excessive lubricant in the center lumen, which may cause occlusion, obstruct blood flow, and delay treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide