The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 device failure 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.

401–425 of 881

  • SevereFDA (Devices)·Z-1213-2020·2020-02-19

    Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk

    Arrow International is recalling 343,105 Epidural Catheterization Kits with FlexTip Plus Catheters because the included loss of resistance syringes may fail, potentially causing dural puncture.

    Product
    Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1185-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1165-2020·2020-02-19

    Pacific Medical Toco M2734A Fetal Monitors Recalled for Unverified Components

    Pacific Medical Group is recalling 466 Toco M2734A fetal monitors serviced with unverified non-OEM components that may fail to detect fetal distress or cause burns.

    Product
    Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1212-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1181-2020·2020-02-19

    Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk

    Arrow International is recalling specific lots of Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1183-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1205-2020·2020-02-19

    Arrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes

    Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes due to potential failures that could result in dural puncture.

    Product
    10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1217-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1154-2020·2020-02-19

    Respironics Ventilator Touchscreen Recall Due to Unresponsive Controls

    Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.

    Product
    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1207-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1182-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1147-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 73 Omega PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0817-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 705 LIFEPAK 15 Monitor/Defibrillator service kits because oxidation may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation

    Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2020·2020-01-15

    Avanos Recalls Haylard Closed Suction Systems Due to Blocked Lumens

    Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics because the central lumen may be blocked, potentially preventing adequate suctioning of airway secretions.

    Product
    Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2020·2019-12-18

    Encore Medical Recalls EMPOWR Locking Femoral Impactor Due to Tip Breakage

    Encore Medical is recalling 410 EMPOWR Locking Femoral Impactors because the tips may break off during surgery. This defect can cause off-axis loading, device failure, and potential long-term complications.

    Product
    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0608-2020·2019-12-11

    Philips HeartStart XL+ Defibrillator Recall for Power-On Failure

    Philips is recalling 24,738 HeartStart XL+ Defibrillator/Monitor units because they may fail to turn on or restart, rendering them unable to return to a ready-for-use state.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide