The Recall Desk

Manufacturer

Halyard Health, Inc

48 recalls in our database name Halyard Health, Inc as the manufacturing or recalling firm.

What the numbers show

Total
48
Critical
0
Severe
2
Most recent
2018-04-25

Of the 48 recalls from Halyard Health, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 48

  • HighFDA (Devices)·Z-1427-2018·2018-04-25

    Halyard Closed Suction System Flex Connectors May Disconnect During Use

    Halyard Health is recalling certain Closed Suction Systems because the Flex Connectors may become loose or disconnect before or during use.

    Product
    Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2018·2018-04-25

    Halyard Closed Suction System Recall Due to Loose Flex Connectors

    Halyard Health is recalling certain Closed Suction Systems because the Flex Connectors may become loose or disconnect before or during use.

    Product
    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2018·2018-04-25

    Halyard Closed Suction System Flex Connectors May Disconnect During Use

    Halyard Health is recalling certain Closed Suction Systems because Flex Connectors may become loose or disconnect before or during use.

    Product
    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2018·2018-04-11

    Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes

    Halyard Health is recalling CORTRAK 2 feeding tubes because the internal stylet may be visible in the exit port window, deviating from specifications.

    Product
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Saline Vials Recalled for Leaking Risk

    Halyard Health is recalling specific lots of 15ml saline vials used in the Turbo-Cleaning Closed Suction System because they may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0118-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Leaking Saline Vials

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0117-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling specific lots of Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0125-2018·2017-11-29

    Halyard Health Recalls NOVAPLUS Endotracheal Suction Kits Due to Leaking Vials

    Halyard Health is recalling NOVAPLUS Endotracheal WET PAK Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0122-2018·2017-11-29

    Halyard Closed Suction System Recalled Due to Saline Vial Leaking Risk

    Halyard Health is recalling specific lots of Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0124-2018·2017-11-29

    Halyard Closed Suction System Saline Vials Recalled for Leaking Risk

    Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing the contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0123-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0119-2018·2017-11-29

    Halyard Closed Suction System Saline Vials Recalled for Potential Leaking

    Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0120-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaks

    Halyard Health is recalling specific lots of Closed Suction Systems because the saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0724-2017·2016-12-14

    Halyard C-Section Drapes Recalled for Manufacturing Variation

    Halyard Health is recalling specific lots of C-Section drapes because a manufacturing variation may prevent the removal of coated release paper, inhibiting easy access to the surgical site.

    Product
    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2016·2016-08-17

    Halyard Health Recalls Coolife Sinergy Radiofrequency Kits Due to Component Mismatch

    Halyard Health is recalling 51 Coolife Sinergy Radiofrequency Kits because the electrode length does not match the cannula length.

    Product
    Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2517-2015·2015-09-09

    Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters

    Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.

    Product
    KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2494-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.

    Product
    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2501-2015·2015-09-09

    Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems

    Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2015·2015-09-09

    Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

    Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning, despite appearing closed.

    Product
    KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2015·2015-09-09

    Halyard KimVent Closed Suction System Recall for Valve Defect

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.

    Product
    KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2015·2015-09-09

    Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems

    Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising airway protection.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2015·2015-09-09

    Halyard KimVent Suction Catheter Thumb Valve Recall

    Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, compromising the closed suction system.

    Product
    KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    Halyard Health is recalling KimVent Multi-Access Port Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.

    Product
    KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2506-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.

    Product
    KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2015·2015-09-09

    Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.

    Product
    KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Halyard Health

American medical equipment manufacturer

Country
United States

Official website

Source: Wikidata (Q16998390), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.