The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
882
Critical
29
Severe
301
Most recent
2026-09-23

Of the 882 device failure recalls we have scored against our rubric, 29 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 301 (34%) 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 882

  • SevereFDA (Devices)·Z-1201-2020·2020-02-19

    Arrow FlexTip Plus Epidural Catheterization Set Recalled for Syringe Failures

    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-B
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1156-2020·2020-02-19

    Medicrea TLIF-B Holder Recalled Due to Potential Rod Separation

    Medicrea International is recalling 14 units of TLIF-B Holders because the inner draw rod may separate from the knob.

    Product
    Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1193-2020·2020-02-19

    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 CA-02220
    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-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-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
  • 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-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-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
  • 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