The Recall Desk

Hazard

Device Defect recalls

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

About this hazard tag

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

1–25 of 184

  • SevereFDA (Devices)·Z-2158-2026·2026-05-20

    Cannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect

    Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.

    Product
    Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2144-2026·2026-05-20

    Medline Cardiac Catheterization Kits Recalled for Particulate Contamination

    Medline Industries is recalling multiple cardiac catheterization kits due to the presence of particulate matter in the fluid path of manifolds. The affected kits were distributed nationwide and internationally.

    Product
    1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2145-2026·2026-05-20

    Medline Cardiac Catheterization Kits Recalled for Particulate Contamination

    Medline Industries is recalling multiple cardiac catheterization kits because particulate contamination has been found within the fluid path of the manifolds used in these kits.

    Product
    1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.

    Product
    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2026·2026-04-29

    Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2026·2026-04-29

    Soft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.

    Product
    Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2026·2026-04-29

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall

    Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1899-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1589-2026·2026-04-08

    Purge Cassettes May Leak in Impella Pump and Assist Sets

    Abiomed is recalling Purge Cassettes used in Impella pump systems worldwide due to increased risk of purge leaks. The cassettes are included in multiple pump set models distributed across 33,107 units.

    Product
    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1449-2026·2026-03-04

    Olympus Model A4741 Inner Sheath Recalled Due to Ceramic Tip Breakage

    Olympus Corporation recalls 91 units of Model A4741 Inner Sheath following complaints that the ceramic tip breaks. The device is used for endoscopic gynecological diagnosis and treatment.

    Product
    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Fracture Risk

    Olympus Corporation recalls 94 units of Model A37004A resection sheath used in urological procedures. Complaints indicate the ceramic tip can break during use.

    Product
    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2026·2026-03-04

    Olympus Inner Sheath Model A2642 Recalled for Breaking Ceramic Tip

    Olympus is recalling the Inner Sheath Model A2642 urological endoscope due to complaints that the ceramic tip breaks. The device has been distributed nationwide.

    Product
    Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2026·2026-03-04

    Olympus Inner Sheath medical device recalled due to ceramic tip breakage

    Olympus Corporation is recalling 1,141 units of the Inner Sheath, Long (Model WA22017T) used in urological and gynecological procedures due to complaints of ceramic tip breakage.

    Product
    Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2026·2026-03-04

    Medline Dialysis Kits Recalled for Defective Silicone Seals

    Medline is recalling 516 dialysis insertion kits due to silicone seal defects that may block fluid flow or cause therapy delays. Affected units risk allowing biological contamination or air to enter the body.

    Product
    Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2026·2026-02-25

    Medline nerve block tray recalled over sterilization equipment calibration

    Medline recalls 448 units of Basic Nerve Block Trays due to equipment calibration issues that may affect sterilization assurance levels of the medical devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2026·2026-01-14

    ICP Monitoring Device Recall: Potential Needle Corrosion in Codman Microsensor Kit

    Integra LifeSciences is recalling the Codman Microsensor Basic Kit due to potential corrosion stains on the included 14-gauge Tuohy Needle. This device is used for intracranial pressure monitoring and corrosion could affect its function.

    Product
    Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2026·2025-12-10

    Medtronic Aurora EV-ICD Defibrillators: Potential Delayed Therapy Delivery

    Medtronic Aurora EV-ICD and Clinical EV-ICD implantable defibrillators may experience delayed high-voltage therapy delivery under rare circumstances. No patient injuries have been reported.

    Product
    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0467-2026·2025-11-19

    Electrosurgical Device Recall: Material Trapping Hazard in Medline LigaSure Exact Dissector

    Medline Industries is recalling the Medline Renewal LigaSure Exact Dissector due to areas on the device that may trap residual material. In rare cases, trapped material could become dislodged.

    Product
    Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2026·2025-11-12

    Incorrect Titanium Screw Packaged with Inclusive Dental Implant

    Prismatik Dentalcraft is recalling Inclusive Titanium Screws (Model 70-1047-COM0117) due to incorrect screws being packaged with dental implants. The defect may compromise implant fit and function.

    Product
    Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0206-2026·2025-10-29

    Salem Sump PVC Tubes Anti-Reflux Valve Breakage During Use

    Cardinal Health is expanding a recall of Salem Sump PVC tubes due to anti-reflux valve breakage from excessive force during use. The company is providing additional usage guidance.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2025·2025-09-10

    TOPS Inserter surgical instrument recalled for missing pins

    PREMIA SPINE LTD is recalling TOPS Inserter instruments (Model 82889) due to potential missing pins at the tip. The recall affects 30 units distributed in Connecticut.

    Product
    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2025·2025-09-10

    Philips Allura Xper X-Ray Systems Recalled for Potentially Missing Component

    Philips is recalling 192 Allura Xper Series interventional fluoroscopic X-ray systems because an air baffle component may be missing from some units. The systems have been distributed in multiple U.S. states and internationally.

    Product
    Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2025·2025-09-10

    CADD Medication Cassette Reservoir Recalled for Potential Medication Leakage

    ICU Medical is recalling certain CADD medication cassette reservoirs worldwide due to weakened bag welds that could allow medication to leak. No illnesses have been reported.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2278-2025·2025-08-20

    Pulsed Field Ablation Catheter Recalled Due to Electrode Band Defects

    Boston Scientific is recalling 445 FARAWAVE 1.0 Pulsed Field Ablation Catheter units nationwide due to potential cracks in electrode bands caused by manufacturing equipment.

    Product
    FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
    Category
    Medical Device
    Distribution
    Distributed nationwide