The Recall Desk

Hazard

Treatment Interruption recalls

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

What the numbers show

Total
24
Critical
1
Severe
1
Most recent
2025-12-24

Of the 24 treatment interruption recalls we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) 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 interruption 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.

1–24 of 24

  • HighFDA (Devices)·Z-0936-2026·2025-12-24

    Dialysis machines recalled over software anomalies that may stop treatment

    Fresenius Medical Care is recalling 115 5008X CAREsystem units over several software anomalies with the potential to impact patient treatment, one of which may result in treatment stop.

    Product
    5008X CAREsystem +CLiC +CDX;
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1972-2025·2025-06-18

    BD Texium Closed System Drug Transfer Devices May Leak at Connector

    BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.

    Product
    BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2025·2025-06-18

    Alaris Pump Infusion Sets may leak at male luer connections

    BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.

    Product
    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2024·2024-06-19

    Fresenius AquaA hemodialysis water purification device pressure control malfunction

    Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis treatment.

    Product
    US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2023·2022-11-02

    ARTIS pheno interventional x-ray system software defect prevents treatment continuation

    Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.

    Product
    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2022·2022-07-27

    BD Connecta Plus3 infusion connector recalled for potential stopcock leakage

    Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.

    Product
    BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2022·2022-07-27

    BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage

    Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.

    Product
    BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2022·2022-07-27

    Nexiva Infusion Device Stopcock May Leak During Treatment

    Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2022·2022-07-27

    BD Connecta Stopcock Recalled for Potential Housing Leakage

    Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2022·2022-07-27

    BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk

    Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2022·2022-07-27

    BD Connecta White 360 Infusion Connector Recalled for Potential Leakage

    Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.

    Product
    BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2022·2022-06-15

    Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation

    Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.

    Product
    Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1651-2021·2021-06-09

    Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk

    FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2773-2020·2020-08-19

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2020·2020-08-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems because aborted irradiations cannot be resumed due to a software loading issue.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2305-2018·2018-07-04

    Siemens Artis Q.zen Biplane Recalled for Display Failure

    Siemens Medical Solutions is recalling two Artis Q.zen biplane systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation or patient transfer.

    Product
    Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2018·2018-07-04

    Siemens Artis zee floor recall due to display failure

    Siemens is recalling 14 Artis zee floor systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation.

    Product
    Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2018·2018-07-04

    Siemens Artis Q Ceiling Recalled for Display Failure After Power Save

    Siemens Medical Solutions is recalling five Artis Q ceiling units because the display may fail to show an image after exiting power save mode, potentially requiring treatment cancellation.

    Product
    Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2018·2018-07-04

    Siemens Artis zee Biplane Recalled for Display Failure After Power Save

    Siemens is recalling 68 Artis zee biplane systems because the large display may remain black after exiting power save mode, potentially requiring treatment cancellation or patient transfer.

    Product
    Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2018·2018-03-28

    Siemens AXIOM Artis angiographic x-ray systems recalled for coolant leaks

    Siemens is recalling 22 AXIOM Artis angiographic x-ray systems because leaking coolant couplings can damage the flat panel detector, potentially requiring treatment cancellation or patient transfer.

    Product
    AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patien
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2122-2017·2017-05-31

    Cardiovascular Systems Recalls Orbital Atherectomy System Saline Infusion Pumps

    Cardiovascular Systems Inc. is recalling 1,396 Saline Infusion Pumps that may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0447-2013·2012-12-12

    Natus Olympic Cool-Cap Recalled Due to Frozen Screen Malfunction

    Natus Medical is recalling 324 Olympic Cool-Cap systems because the control module screen may freeze, causing the device to stop cooling infants without visible alarm.

    Product
    The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2012·2012-06-27

    Natus Olympic Cool-Cap System Recalled Due to Power Supply Failure

    Natus Medical is recalling 181 Olympic Cool-Cap Systems because the power supply may fail without warning, interrupting cooling treatment for infants.

    Product
    Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides sel
    Category
    Medical Device
    Distribution
    Distributed nationwide