The Recall Desk

Hazard

Delayed Treatment recalls

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

What the numbers show

Total
61
Critical
0
Severe
6
Most recent
2026-04-22

Of the 61 delayed treatment recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (10%) 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 delayed treatment 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 61

  • HighFDA (Devices)·Z-1806-2026·2026-04-22

    Yeastone Broth recalled because it may report incorrect susceptibility results

    Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.

    Product
    Yeastone Broth, 11ML, 10/BOX YY3462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2026·2025-10-29

    Oral thermometer probes recalled after being programmed with rectal configuration

    Baxter is recalling 5,209 oral probes for Welch Allyn SureTemp Plus thermometers that were inadvertently programmed with the rectal probe configuration and may read low.

    Product
    Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2025·2025-03-26

    EAR PACK Medical Device Recalled Over Unconfirmed Sterilization

    American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.

    Product
    EAR PACK , Model No SFEA12A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2025·2025-02-05

    Infinity Central Station speakers may fail to produce critical patient alarms

    Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.

    Product
    Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2024·2024-08-14

    Philips IntelliVue Patient Monitors lack critical software monitoring options

    Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.

    Product
    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2024·2024-01-24

    FreeStyle Libre 3 App may lose signal on Android 13 devices

    Abbott is recalling FreeStyle Libre 3 App on Android 13 devices due to signal loss that may prevent users from receiving glucose readings and alarms, potentially delaying necessary treatment.

    Product
    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2024·2024-01-17

    BIOFIRE Respiratory Panel 2.1 recalled for false negative manufacturing defect

    BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.

    Product
    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0357-2024·2023-11-29

    Medical Device Cartridges Recalled for Blood Oxygen Reading Errors

    Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0155-2024·2023-11-01

    SOZO Bilateral Arm L-Dex Software inadequate lymphedema detection sensitivity

    Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.

    Product
    SOZO Bilateral Arm L-Dex Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2023·2023-08-23

    Mahurkar Dialysis Catheters Recalled for Center Lumen Obstruction

    Covidien is recalling 1,099 MAHURKAR dialysis catheters worldwide due to excessive silicone lubricant that can block the center lumen, potentially delaying treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0966-2022·2022-05-04

    Ventilator Audible and Visual Alarms May Not Activate During Alarm States

    The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.

    Product
    Puritan Bennett 980 Series Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0234-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk

    Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2021·2021-03-31

    Meridian ImmunoCard Mycoplasma EIA Recalled for Potential False-Negative Results

    Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.

    Product
    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0745-2021·2021-01-06

    Westmed Adult Elongated Oxygen Mask Recalled for Loose Fitment

    Westmed is recalling 16,000 adult elongated oxygen masks because the tube connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2021·2021-01-06

    Westmed Adult Oxygen Mask Recall Due to Potential Loose Fitment

    Westmed is recalling 6,000 units of Adult Elongated O2/CO2 Masks because the oxygen delivery tube may not connect securely to the mask adapter, potentially delaying treatment.

    Product
    REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0743-2021·2021-01-06

    Westmed Adult Elongated CO2/O2 Mask Recall for Loose Fitment

    Westmed is recalling 600 units of Adult Elongated CO2/O2 Masks because the tubing connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2021·2021-01-06

    Westmed Elongated Oxygen Mask Recalled for Loose Tube Connection

    Westmed is recalling 3,000 units of the REF 3102-E Elongated Oxygen Mask because the tube connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2021·2021-01-06

    Westmed Adult CO2/O2 Mask Recall Due to Loose Tube Fitment

    Westmed is recalling 1,200 units of Adult CO2/O2 Masks because the oxygen delivery tube may become loose, potentially delaying treatment.

    Product
    REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2021·2021-01-06

    Westmed Non-Rebreather Masks Recalled for Loose Oxygen Tube Fitment

    Westmed is recalling 37,300 non-rebreather masks because the oxygen tube connection may become loose, potentially delaying patient treatment.

    Product
    Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0636-2021·2020-12-23

    Kowa VK-2s Software Recall for Potential Patient Data Deletion

    Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.

    Product
    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2021·2020-12-16

    Philips IntelliVue MP2 Patient Monitors Recalled for Speaker Failure

    Philips is recalling two IntelliVue MP2 patient monitors because speaker failures may prevent audible alarms, potentially delaying patient treatment.

    Product
    Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2021·2020-12-16

    Philips IntelliVue X2 Multi Measurement Server Speaker Failure Recall

    Philips is recalling 16 IntelliVue X2 Multi Measurement Servers because speaker failures may prevent audible alarms, potentially delaying patient treatment.

    Product
    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport insi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2021·2020-10-28

    BD Nexiva Closed IV Catheter System Recalled for Dull Needles

    Becton Dickinson is recalling 12,020 units of BD Nexiva Closed IV Catheter Systems due to dull needles that may delay medical treatment.

    Product
    BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2020·2020-07-15

    Kentec Medical Recalls ENFit Enteral Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 170 ENFit enteral feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2518-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states