The Recall Desk

Hazard

Catheter Defect recalls

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

What the numbers show

Total
40
Critical
0
Severe
5
Most recent
2026-07-08

Of the 40 catheter defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (13%) 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 catheter defect 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.

26–40 of 40

  • HighFDA (Devices)·Z-2486-2026·2026-06-24

    Medline cardiac surgery and ECMO packs contain substandard catheters

    Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2026·2026-06-24

    Medline bioburden test and cystectomy kits contain substandard catheters

    Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2026·2026-06-24

    Medline gynaecology laparoscopy packs contain catheters failing performance specifications

    Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2026·2026-06-24

    Medline urethroplasty kits contain catheters failing performance specifications

    Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2026·2026-06-24

    Medline open heart and cardiac kits contain catheters failing specifications

    Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2026·2026-06-24

    Medline vasectomy reversal kits contain catheters failing performance specifications

    Medline Bilateral Micro Vasectomy Reversal kits are being recalled because representative samples did not meet applicable catheter performance specifications. 588 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2026·2026-06-24

    Medline nursing kits contain catheters failing applicable performance specifications

    Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2026·2026-06-24

    Medline tracheostomy and tonsil kits contain catheters failing specifications

    Medline procedure kits including adult tracheostomy tube insertion, T&A and ear packs are being recalled because sample catheters did not meet performance specifications. 217,390 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0991-2025·2025-02-05

    Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect

    Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.

    Product
    Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2025·2025-02-05

    Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect

    Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.

    Product
    Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2024·2024-08-07

    BD Insyte Autoguard BC IV Catheter Recalled for Tubing Defect and Leakage

    Becton Dickinson has recalled certain BD Insyte Autoguard BC IV catheters due to potential holes in the catheter tubing that could cause leakage during insertion. The recall involves 26,400 units distributed in the United States.

    Product
    BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to…
    Category
    Medical Device
    Distribution
    1 state
  • 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-1614-2024·2024-05-01

    Route 92 Medical Reperfusion System Recalled for Potential Device Separation

    Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.

    Product
    Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1379-2023·2023-04-19

    Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

    Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

    Product
    Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0667-2022·2022-03-02

    Bard Surestep Intermittent Catheter Tray Recalled for Connection Leaks

    C.R. Bard Inc recalled 1,620 units of Bard Surestep Intermittent Catheter Tray because the catheter may leak where it connects to the drain bag. No injuries have been reported.

    Product
    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
    Category
    Medical Device
    Distribution
    Distributed nationwide