The Recall Desk

Hazard

Device Defect recalls

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

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) 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 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.

76–100 of 450

  • HighFDA (Devices)·Z-3039-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Defects

    Medline Convenience kits containing defective plastic syringes are being recalled worldwide due to leaks, breakage, and quality issues that may pose patient health risks.

    Product
    Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2995-2024·2024-09-18

    Medline cardiac and surgical procedure convenience kits recalled worldwide

    Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.

    Product
    Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3042-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3131-2024·2024-09-18

    Surgical Dissector Recalled for Brown Discoloration on Hinge Area

    Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.

    Product
    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2588-2024·2024-09-04

    Smiths Medical Bivona Tracheostomy Tubes Recalled for Flange Tear Risk

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected lots include neonatal, pediatric, and adult sizes distributed worldwide with 177,340 units impacted.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2743-2024·2024-09-04

    Medline procedural kit syringes recalled for leaks and breakage

    Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2886-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2024·2024-09-04

    Breast biopsy kits recalled due to defective syringes with leaks and breakage

    Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2829-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

    BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2919-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Quality Concern

    Beaver Visitec International is recalling 227 units of BVI CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to a quality concern affecting those syringes.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2631-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2627-2024·2024-09-04

    Medline Procedure Packs With Syringes Recalled for Quality Defects

    Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2850-2024·2024-09-04

    Medical Syringes in BVI CustomEyes Procedure Packs Recalled

    BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. The recall involves 315 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001176;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2823-2024·2024-09-04

    BVI CustomEyes Procedure Packs with defective Sol-M syringes recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These packs were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2807-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., due to a voluntary recall of those syringes. The recall affects 154 units nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000426;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2847-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary recall by the syringe manufacturer. The recall affects 43 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2784-2024·2024-09-04

    FDA recalls BVI CustomEyes ophthalmic procedure packs nationwide

    Beaver Visitec International initiated a voluntary recall of BVI CustomEyes Procedure Packs containing surgical syringes (Part Number 584550, Lot 6048601) distributed nationwide. The Class II recall was initiated on July 26, 2024.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2808-2024·2024-09-04

    BVI Recalls CustomEyes Procedure Packs Containing Recalled Sol-M Syringes

    BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Component

    Beaver Visitec International recalled BVI CustomEyes Procedure Packs containing defective 1ml syringes manufactured by Sol-Millennium Medical. The 68-unit recall involves procedure packs distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000709;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2878-2024·2024-09-04

    BVI CustomEyes Procedure Packs With Recalled Sol-M Syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, which are subject to a voluntary recall. 37 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001511;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2785-2024·2024-09-04

    BVI Voluntarily Recalls CustomEyes Procedure Packs Containing Sol-M Syringes

    BVI is voluntarily recalling CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The affected products were distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584587;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2926-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2887-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Syringes

    BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2925-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled due to incorrect syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical instead of the intended product. The recall involves 57 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2876-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide containing syringes from Sol-Millennium Medical's voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;
    Category
    Medical Device
    Distribution
    Distributed nationwide