The Recall Desk

Hazard

Defective Component recalls

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

What the numbers show

Total
100
Critical
1
Severe
5
Most recent
2025-06-11

Of the 100 defective component recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) 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 defective component 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.

51–75 of 100

  • HighFDA (Devices)·Z-1547-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 90 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1228-2017·2017-03-01

    Arrow International Recalls Vascular Catheter Introduction Kits Due to Flaring Sheaths

    Arrow International Inc is recalling 215,703 vascular catheter introduction kits nationwide because complaints were received regarding peel away sheaths flaring.

    Product
    Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2017·2017-01-18

    Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion

    Hospira is voluntarily recalling one lot of Minibore Extension Sets due to a confirmed report of solvent occlusion that may prevent priming and delay therapy.

    Product
    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2017·2016-12-28

    Smiths Medical Recalls Acuvance 2 Safety Catheters Due to Valve Defects

    Smiths Medical is recalling 26,750 Acuvance 2 Safety Catheters because some devices have missing or incorrectly positioned side port valves.

    Product
    Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The cath
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0733-2017·2016-12-21

    Cook Medical Recalls Central Venous Catheter Trays Due to Incorrect Needles

    Cook Medical is recalling 99 units of Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays because they may contain incorrect needles, potentially preventing wire guide passage.

    Product
    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2250-2016·2016-07-27

    Centurion Convenience Kits Recalled Due to Defective Medtronic Light Glove

    Centurion is recalling 483 convenience kits containing Medtronic light gloves with potential splits or holes that could transfer microorganisms to patients.

    Product
    Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0817-2016·2016-02-24

    Nihon Kohden MEE-1000A Neuromaster Accessories Recalled for Defective Circuit Boards

    Nihon Kohden America Inc is recalling MEE-1000A Neuromaster accessories due to defective printed circuit boards that failed to prevent unintentional current flow.

    Product
    MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2790-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrator Component

    Terumo is recalling 15 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 High Performance Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling 5 Custom Cardiovascular Procedure Kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2791-2015·2015-09-30

    Terumo Cardiovascular Procedure Kits Recalled Due to Defective Hemoconcentrators

    Terumo is recalling 19 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2015·2015-07-29

    Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk

    Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.

    Product
    ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2015·2015-07-08

    Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 390 cases distributed nationwide, in Canada, and in Germany.

    Product
    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2015·2015-06-10

    Alcon Custom Pak Recalled for Potential Glove Splits and Holes

    Alcon Research, Ltd. is recalling Alcon Custom Paks because the Devon Light Glove component may have splits or holes, which could lead to surgical site infections.

    Product
    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1663-2015·2015-06-03

    Siemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings

    Siemens is recalling Liquid Waste Bottle Kits for Immulite 2000 systems because some bottle openings are undersized or deformed, preventing caps from closing securely.

    Product
    Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1055-2015·2015-02-11

    BD 10 mL Syringes Recalled Due to Improperly Seated Stopper

    Becton Dickinson is recalling 564,000 units of 10 mL syringes because the stopper is not properly seated in the syringe.

    Product
    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports

    Smith & Nephew is recalling RENASYS EZ and EZ Plus 800 mL canisters with deformed inlet ports on the lid. The defect may affect the collection of wound exudate during negative pressure wound therapy.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2261-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1752-2014·2014-06-18

    Stryker 4.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 281 units of 4.0mm Round Fluted Burs because some may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1767-2014·2014-06-18

    Stryker 6.0mm Egg Bur Recall Due to Missing Notches

    Stryker is recalling 65 units of 6.0mm Egg Bur sterile surgical instruments because some units have missing or partial notches.

    Product
    Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1761-2014·2014-06-18

    Stryker Elite Bur Recall Due to Missing Notches

    Stryker is recalling 2.0mm Tapered Round Elite Burs because some units have missing or partial notches. The devices are used for cutting bone during surgery.

    Product
    Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applicati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1775-2014·2014-06-18

    Stryker Neuro Drill Soft Touch Recalled for Missing Notches

    Stryker is recalling 802 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide