The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 malfunction 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.

1151–1175 of 1800

  • HighFDA (Devices)·Z-2386-2018·2018-07-18

    GE Medical Systems Recalls Discovery IGS 730 X-ray Systems

    GE Medical Systems is recalling 102 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors that may cause loss of imaging mode.

    Product
    Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-2348-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD-01
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2337-2018·2018-07-11

    Terumo Recalls Angio-Seal Evolution Vascular Closure Devices

    Terumo Medical Corp is recalling 240 Angio-Seal Evolution Vascular Closure Devices because they were released before required validation was completed.

    Product
    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2336-2018·2018-07-11

    Arrow International Recalls Multi-Lumen Central Venous Catheter Sets

    Arrow International is recalling 1,200 multi-lumen central venous catheter sets due to increased resistance during insertion, which may cause procedural delays.

    Product
    Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2302-2018·2018-07-04

    Intersurgical Flexible Breathing Circuit Recall Due to Exhalation Port Blockage Risk

    Intersurgical Inc is recalling 1,340 Flexible Smoothbore Breathing Circuits because the tubing may block the exhalation port during assembly, posing a serious health risk to patients.

    Product
    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2317-2018·2018-07-04

    Medtronic Model 53401 Pacemakers Recalled for Unexpected Power Reset

    Medtronic is recalling 1,108 Model 53401 temporary external pacemakers because they may revert to nominal settings during use due to an unexpected power on reset.

    Product
    Single Chamber Temporary External Pacemaker, Model 53401
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2154-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 110 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery to the patient.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2053-2018·2018-06-13

    Siemens ADVIA Centaur BNP Assay Recalled for Potential Analyzer Malfunction

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP assays because they may cause analyzer malfunction or reduced dilution recovery when used with specific diluents.

    Product
    ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-2041-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2040-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Devices

    Torax Medical is recalling LINX Reflux Management Systems because a bead component may separate from an adjacent wire link, potentially resulting in a discontinuous or open device.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Lapa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1923-2018·2018-05-30

    Baxter Prismaflex 5.10 US Control Units Recalled for Firmware Update

    Baxter Healthcare is recalling 1,256 Prismaflex 5.10 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1926-2018·2018-05-30

    Baxter Recalls Prismaflex 7.20 US Control Units for Firmware Update

    Baxter Healthcare is recalling 231 Prismaflex 7.20 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1925-2018·2018-05-30

    Baxter Recalls Prismaflex Control Units for Firmware Update

    Baxter Healthcare is recalling 557 Prismaflex 7.XX US control units worldwide to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1924-2018·2018-05-30

    Baxter Prismaflex Control Units Recalled for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex control units to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1922-2018·2018-05-30

    Baxter Recalls Prismaflex Systems for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex Systems to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) thera
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1830-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Staplers for Missing Sled Component

    COVIDIEN Medtronic is recalling approximately 171,271 Endo GIA universal staplers because a missing sled component may prevent proper staple deployment. This defect can lead to bleeding or leakage of luminal contents during surgery.

    Product
    (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1816-2018·2018-05-23

    COVIDIEN Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component

    COVIDIEN MEDTRONIC is recalling 171,271 Endo GIA Universal Articulating Loading Units because a missing sled component may prevent proper staple deployment, risking bleeding or leakage during surgery.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled

    COVIDIEN Medtronic is recalling Endo GIA universal stapler kits because a missing sled component may prevent proper staple deployment, risking bleeding or leakage.

    Product
    BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1838-2018·2018-05-23

    COVIDIEN Medtronic Recalls VATS Lobectomy Kits Due to Missing Sled Component

    COVIDIEN Medtronic is recalling 171,271 VATS lobectomy kits because the device may be missing a sled component. This defect can cause failure to form a staple line, leading to bleeding or leakage during surgery.

    Product
    (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Defect

    Ethicon Endo-Surgery is recalling 1,500 units of 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1885-2018·2018-05-23

    Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Issues

    Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1730-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1719-2018·2018-05-16

    Datascope recalls custom tubing kits with potential Better Bladder seal defect

    Datascope is recalling nine custom tubing kits because a seal defect in the Better Bladder device may allow air entry, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
    Category
    Medical Device
    Distribution
    13 states