The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device malfunction 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.

351–375 of 1800

  • HighFDA (Devices)·Z-1891-2024·2024-06-05

    Tri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling

    Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.

    Product
    Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2024·2024-06-05

    Medline medical procedure kits recalled for potential needle guide ring detachment

    Medline is recalling 12,994 paracervical and pudendal procedure kits because the Trumpet Needle Guide ring can detach when excessive pressure is applied, potentially causing injury.

    Product
    Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure conve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1812-2024·2024-05-29

    BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm

    Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.

    Product
    BiPAP V30 Auto Ventilator, Part Number 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2024·2024-05-29

    Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance

    Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.

    Product
    Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Guide Sheave Failure Recall

    Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2024·2024-05-29

    Medline non-sterile syringes recalled for out-of-specification manufacturing

    Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Recalled for Being Outside Cleared Specifications

    Jiangsu Shenli Medical is recalling 33,600 MEDLINE 10ml non-sterile syringes (Model 91856) because they fall outside the FDA-approved specifications, potentially affecting their function.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Non-Compliant Manufacturing Specifications

    Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2024·2024-05-29

    Non-sterile Medline syringes recalled for exceeding FDA clearance specifications

    Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1657-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled for Material Delamination

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination of the inner lining. The defect prevents guidewire advancement and affects 330 units worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1665-2024·2024-05-22

    Expo Selective Angiographic Catheters Recalled for Material Delamination and Detachment

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1681-2024·2024-05-22

    Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues

    Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1671-2024·2024-05-22

    Expo 5F Cardiac Catheters recalled due to polyurethane delamination

    Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1666-2024·2024-05-22

    Boston Scientific Expo 5F catheters recalled for material delamination

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The recall affects 46,860 units distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1679-2024·2024-05-22

    Boston Scientific Expo 5F Catheters recalled due to material delamination defect

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1652-2024·2024-05-22

    Cardiac Catheters Recalled Due to Delamination and Device Malfunction

    Boston Scientific is recalling 8,725 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1669-2024·2024-05-22

    Expo 5F Selective Angiographic Cardiac Catheters: Guidewire Advancement Failure Risk

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1650-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment in the catheter's inner lining, which prevents proper advancement of the guidewire.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1647-2024·2024-05-22

    Angiographic Catheters Recalled for Polyurethane Delamination and Malfunction

    Boston Scientific recalls Expo 5F angiographic catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The recall affects 3,127 units in specific batches distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1661-2024·2024-05-22

    Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment

    Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1642-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled for Material Delamination

    Boston Scientific is recalling certain Expo 5F cardiac catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during procedures. The recall affects 290 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1676-2024·2024-05-22

    Expo 5F Catheters Recalled for Guidewire Advancement Failure

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The issue affects 440 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1653-2024·2024-05-22

    Expo 5F cardiac angiographic catheters recalled for delamination defect

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the catheter lumen.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1662-2024·2024-05-22

    Cardiac Catheters Recalled for Material Delamination Risk

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters worldwide due to polyurethane delamination and material detachment that prevents guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1667-2024·2024-05-22

    Expo 5F Angiographic Catheters Recalled for Guidewire Advancement Failure

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states