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.

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 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.

726–750 of 881

  • HighFDA (Devices)·Z-2747-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Dysplasia Cup Recall

    Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled

    Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2015·2015-09-16

    Smith & Nephew Birmingham Hip Resurfacing Femoral Head Recall

    Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.

    Product
    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2015·2015-09-09

    Wright Medical Recalls CrossCHECK Non-Locking Screws Due to Malfunction Risk

    Wright Medical Technology is recalling 5,687 CrossCHECK Non-Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.

    Product
    CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2015·2015-09-09

    Wright Medical CrossCHECK Locking Screw Recall for Intraoperative Malfunction Risk

    Wright Medical Technology is recalling 107 CrossCHECK Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.

    Product
    CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2326-2015·2015-08-12

    Aesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect

    Aesculap is recalling 10 S4C Occiput Torque Wrenches because improper reassembly after reprocessing caused a screw to break during implantation.

    Product
    S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2015·2015-08-12

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters due to reports of tip splits or separation, which may cause loss of function or complications.

    Product
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2015·2015-07-15

    Philips GoSafe Communicator 7000L Personal Emergency Response System Recall

    Lifeline Systems is recalling 38 Philips GoSafe Communicator 7000L units because they may fail to sense the phone line under unusual landline conditions.

    Product
    Philips GoSafe Communicator 7000L Personal emergency response system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2015·2015-07-08

    Atrium Medical Recalls EXPRESS Dry Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.

    Product
    EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1809-2015·2015-07-01

    Teleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage

    Teleflex Medical is recalling 9,333 units of Lifesaver Single Patient Use Manual Resuscitators because the intake port may be blocked, causing the bag to fail to fill.

    Product
    Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1736-2015·2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1738-2015·2015-06-17

    Smith & Nephew R3 Constrained Liner Recalled for Locking Groove Defect

    Smith & Nephew is recalling 40 units of R3 Constrained Liners because the locking groove is oversized, preventing the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2015·2015-06-17

    HeartWare HVAD Recall Issued for Discolored and Cracked Driveline Outer Sheath

    HeartWare Inc is recalling HVAD systems due to complaints of discolored and cracked driveline outer sheaths. The recall affects 3,747 units currently in use.

    Product
    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1687-2015·2015-06-03

    Terumo Advanced Perfusion System 1 Recalled for Power Loss Risk

    Terumo is recalling 1,713 Advanced Perfusion System 1 units worldwide due to a risk of losing system power during critical medical procedures.

    Product
    100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2015·2015-04-22

    Bard ConQuest PTA Balloon Dilatation Catheter Recalled for Deflation Risk

    Bard Peripheral Vascular is recalling specific lots of the ConQuest PTA Balloon Dilatation Catheter due to a risk of deflation-related issues.

    Product
    Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1362-2015·2015-04-08

    Pega Medical Recalls GAP Nail 4.8mm Due to Distal Screw Hole Failures

    Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail because of failures at the distal cortical screw holes, primarily in patients with specific bone conditions.

    Product
    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and hu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1356-2015·2015-04-08

    Medtronic Temporary Pacemaker Recalled for Battery Connection Failure

    Medtronic is recalling 6,040 Model 5392 temporary pacemakers because specific AA batteries may fail to connect, potentially stopping pacing therapy.

    Product
    Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2015·2015-03-25

    Transonic Hemodialysis Monitor Recall Due to Inaccurate Flow Measurements

    Transonic Systems Inc is recalling Hemodialysis Monitors that may display zero or low flow values, preventing accurate measurements during dialysis.

    Product
    Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2015·2015-03-25

    Puritan Absorbent Foam Tipped Applicator Recall Due to Shaft Breakage

    Puritan Medical Products is recalling sterile absorbent foam tipped applicators because the shafts may break, preventing adequate patient specimen collection.

    Product
    Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1145-2015·2015-03-04

    Spacelabs Healthcare Recalls qube Compact Monitors for Boot Failure

    Spacelabs Healthcare is recalling 2,955 qube Compact Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1144-2015·2015-03-04

    Spacelabs XPREZZON Bedside Monitors Recalled for Boot Failure

    Spacelabs Healthcare is recalling XPREZZON Bedside Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends a
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0917-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis

    Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.

    Product
    Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific ao
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0887-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide