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.

26–50 of 100

  • ModerateFDA (Devices)·Z-0563-2023·2022-12-21

    DeRoyal Extremity Trays Recalled Due to Affected 3M Steri Drapes

    DeRoyal is recalling its EXTREMITY TRAY procedure packs because they contain recalled 3M Health Care Steri Drapes. The affected kits are distributed across multiple U.S. states.

    Product
    DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0314-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled drape components

    Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).

    Product
    regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0313-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective Component Drapes

    ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.

    Product
    regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0317-2023·2022-11-30

    Surgical Urology Kits Recalled Due to Defective 3M Drapes

    ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.

    Product
    regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1380-2022·2022-07-20

    Tibial Prosthetic Component Recall: Blind Screws Cannot Be Loosened Intraoperatively

    Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.

    Product
    Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0251-2022·2021-11-24

    REGARD Core Biopsy Tray Recalled for Out-of-Specification Component

    ROi CPS LLC recalled 1,200 REGARD Core Biopsy Trays distributed nationwide because a Povidone-Iodine swabstick component supplied by PDI, Inc. was manufactured out of specifications.

    Product
    REGARD Core Biopsy Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1353-2021·2021-04-14

    Gf Health Products Recalls Drop Arm Versamode Due to Incorrect Casters

    Gf Health Products is recalling 66 units of the Drop Arm Versamode because the front casters are incorrect. The devices were distributed in the US and internationally.

    Product
    Drop Arm Versamode"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled Due to Oversized O-Ring Defect

    Cardinal Health is recalling 1,960 NPWT Occlusion Detection Canisters because an oversized O-ring may prevent proper installation into the device connector.

    Product
    Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2020·2020-06-17

    ROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes

    ROi CPS LLC is recalling 40 custom procedure kits because they contain PosiFlush Syringes from a lot previously recalled by BD.

    Product
    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1353-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0969-2020·2020-02-12

    Cook Percutaneous Pigtail Nephrostomy Set Recalled for Wire Guide Loading Error

    Cook Inc. is recalling Percutaneous Pigtail Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver Elite sets because cracks in the bowl core may trap fluid, causing incomplete washing of recovered blood.

    Product
    JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2020·2019-11-06

    Centurion Medical Recalls Port Access Kits Due to Needle Issue

    Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.

    Product
    Kit, Port Access Product Code: DYNDC1582A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0253-2020·2019-11-06

    Centurion Medical Recalls Port Full Access Tray Kits in Illinois

    Centurion Medical Products Corporation is recalling 240 Port Full Access Tray kits in Illinois due to a supplier-initiated recall of GRIPPER Needles.

    Product
    Port full Access Tray Product Code: DT19330
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2152-2019·2019-08-14

    SenTec Membrane Changer Recall Due to Electrolyte Application Defect

    SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2019·2019-08-14

    SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure

    SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0471-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect

    Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.

    Product
    1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2034-2018·2018-06-06

    Joerns Healthcare Recalls ProCair Mattresses Due to Missing Air Shutoff Valves

    Joerns Healthcare is recalling specific ProCair and P.R.O. Matt mattresses because they were supplied with connectors lacking required internal shutoff valves, which can cause air to escape from the mattress cells.

    Product
    ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent dec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2018·2018-05-23

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Strips Due to Defect

    Beckman Coulter is recalling a subset of iChem VELOCITY Urine Chemistry Strips because an incorrect pad may cause false negative results for leukocytes.

    Product
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2018·2018-03-07

    Cook Recalls Wills-Oglesby Percutaneous Gastrostomy Sets Due to Wire Guide Defect

    Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 180 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states