| RECALL REASON DESCRIPTION |
Total (n) |
n% |
| Not authorized, cleared, or approved by the FDA |
11 |
5.21% |
| Risk associated with catheter hub defect |
9 |
4.26% |
| Risk of inaccurate or false results |
9 |
4.26% |
| Risk of explosion/smoke/ burn injury to patients |
7 |
3.31% |
| Unanticipated system shutdowns |
7 |
3.31% |
| Risk of leaks potentially exposing providers and patients to hazardous/toxic substances |
7 |
3.31% |
| Software configuration issues/ software malfunction |
7 |
3.31% |
| Risk of exposure to harmful chemicals/aluminum |
7 |
3.31% |
| Faulty alarms/ alarm failures |
6 |
2.84% |
| Risk of cracked or separated bezel repair posts |
5 |
2.36% |
| Risk of device separation during usage |
5 |
2.36% |
| Risk of bacterial/ fungal contamination |
4 |
1.89% |
| Risk of tip damage occurring during use |
4 |
1.89% |
| Risk of over-infusion and under-infusion |
4 |
1.89% |
| Lack of sterIlity/ sterilisation procedure |
3 |
1.42% |
| Risk of errors in medication labeling |
3 |
1.42% |
| Risk of battery failure |
3 |
1.42% |
| Risk of keys getting stuck or becoming unresponsive |
3 |
1.42% |
| Incompatibilities with syringe pumps |
2 |
0.94% |
| Foreign substances are present in the air pathway |
2 |
0.94% |
| Unforeseen short battery run times |
2 |
0.94% |
| Potential for reduced oxygen supply |
2 |
0.94% |
| Risk of moisture ingress may lead to electrical shorts and shortened battery life |
2 |
0.94% |
| Potential electrical failure, short circuit |
2 |
0.94% |
| Risk of breaks and tears during setup process |
2 |
0.94% |
| Balloon deflation and separation concern |
2 |
0.94% |
| Risk of device fracture |
2 |
0.94% |
| Due to an Impaired or Inability to turn the drive |
1 |
0.47% |
| Failure to detect air in the line |
1 |
0.47% |
| Due to damage to the connector piece causing unexpected disconnections |
1 |
0.47% |
| Malfunctions that cause unintended movement of the robotically assisted surgical device |
1 |
0.47% |
| Blood or heparin leaking back or from syringe |
1 |
0.47% |
| Potential incorrect indication of completed infusion |
1 |
0.47% |
| Stolen defective products |
1 |
0.47% |
| The unit may over-insufflate (inflate) air into the body with no warning or alarm |
1 |
0.47% |
| Power management printed circuit board assemblies not meeting ventilator standards |
1 |
0.47% |
| Leaks and shortcircuits |
1 |
0.47% |
| Inability to exit MRI mode |
1 |
0.47% |
| Not opening properly |
1 |
0.47% |
| Failures in gas loss and gas gain lead to operational issues |
1 |
0.47% |
| Risk of blood clots |
1 |
0.47% |
| Defibrillation concerns: energy reduction, unintended voltage, or inaccurate readings possible |
1 |
0.47% |
| Motor damage risk post transcatheter aortic valve replacement (TAVR) stent contact |
1 |
0.47% |
| Elevated risk of air embolism |
1 |
0.47% |
| Risk of inadequate energy output in high voltage therapy |
1 |
0.47% |
| False-negative troponin may delay or miss myocardial infarction diagnosis |
1 |
0.47% |
| Manifold failure may lead to gas leaks, interrupting neonatal therapy |
1 |
0.47% |
| Risk of components becoming loose or detached, potentially restricting breathing support |
1 |
0.47% |
| Risk of potentially delivering inaccurate or insufficient therapy |
1 |
0.47% |
| Risk of insufficient ventilation and other injuries due to cracked manifolds |
1 |
0.47% |
| Potential silicone foam adhesion failure and presence of residual PE-PUR foam debris |
1 |
0.47% |
| Risk of detector fall posing a potential injury to patients |
1 |
0.47% |
| Challenges leading to therapy delay, interruption, or under-delivery |
1 |
0.47% |
| Possibility of unintentional extended pump stops due to critical controller failure |
1 |
0.47% |
| Risk of potential false susceptibility results |
1 |
0.47% |
| Risk of radiofrequency interference with nearby medical equipment |
1 |
0.47% |
| Potential risks: battery swelling, leakage, or severe overheating |
1 |
0.47% |
| Risk: splitting or detaching may cause leakage, impacting air supply |
1 |
0.47% |
| Safety concerns related to magnets that might impact specific medical devices |
1 |
0.47% |
| Risk of unintentional extended pump stop in case of controller critical failure |
1 |
0.47% |
| Risk of airway obstruction |
1 |
0.47% |
| Risk of inaccurate intracranial pressure readings |
1 |
0.47% |
| Risk of breathing support interruption due to potential water ingress |
1 |
0.47% |
| Risk: Short circuit alert and reduced energy shock during therapy |
1 |
0.47% |
| Issues potentially causing delayed delivery of treatment |
1 |
0.47% |
| Damaged or fractured power switches in the suction system |
1 |
0.47% |
| Risk of respiratory distress in ventilated patients during home use |
1 |
0.47% |
| Defect in the pump weld |
1 |
0.47% |
| An issue that may lead to ventilator cessation with or without alarms |
1 |
0.47% |
| Risk of misplaced enteral tubes that could result in patient harm |
1 |
0.47% |
| Recalls DiaTrust COVID-19 Ag Rapid Test Kits sent to unauthorized users |
1 |
0.47% |
| Risk of capsule breakage during use |
1 |
0.47% |
| Distributed to customers without proper training for safe nasopharyngeal swab collection |
1 |
0.47% |
| Risk of ventilator cessation due to expired adhesive, with or without an alarm |
1 |
0.47% |
| Hazards associated with PE-PUR foam |
1 |
0.47% |
| Reports of filter breakage during retrieval |
1 |
0.47% |
| Potential risk of inaccurate biopsy depth gauge cycle view |
1 |
0.47% |
| Assembly error during manufacturing |
1 |
0.47% |
| Defective plunger in prefilled syringe (0.9% sodium chloride) |
1 |
0.47% |
| Possible cybersecurity vulnerabilities |
1 |
0.47% |
| Decreased gas flow to patients during anesthesia |
1 |
0.47% |
| Risk of marker bands moving or dislodging |
1 |
0.47% |
| Potential for fractures in the delivery system during device placement, retrieval, or movement |
1 |
0.47% |
| Potential issue with cracked or separated bezel repair posts |
1 |
0.47% |
| Potential for air re-entering the syringe, leading to an air embolism |
1 |
0.47% |
| Absence of Instructions for Use for the safety scalpel N11 |
1 |
0.47% |
| Potential for neurological adverse events, mortality, and the risk of failure to restart |
1 |
0.47% |
| Risk of transition to safety mode |
1 |
0.47% |
| Potential health hazards associated with PE-PUR sound abatement foam |
1 |
0.47% |
| Potential for incorrectly low readings |
1 |
0.47% |
| Inaccurate syringe marks risk over/underdose |
1 |
0.47% |
| Risk of stent migration poses a potential concern in medical interventions |
1 |
0.47% |
| Revised details on carrying case, driveline cover, and controller power-up issues |
1 |
0.47% |
| Risk of controller port damage |
1 |
0.47% |
| Risk of stent fractures and type III endoleaks |
1 |
0.47% |
| Risk of fragmented O-ring pieces entering arteries during use |
1 |
0.47% |
| Potential for broken or bent needles |
1 |
0.47% |
| Potential delay or failure in restarting after pump cessation |
1 |
0.47% |
| Failure to correctly secure Q-Link Strap Lock (Q-Link 1 Strap Lock) to S65 hook |
1 |
0.47% |
| Device damage due to manufacturing error |
1 |
0.47% |
| Quality problems |
1 |
0.47% |
| Potential for incorrect display of syringe types and/or sizes |
1 |
0.47% |
| Damaged connectors, missing battery screws, and broken hinge posts with frame damage |
1 |
0.47% |
| Risk of medication delivery error |
1 |
0.47% |
| Partial or complete image loss during operation |
1 |
0.47% |
| Potential breakdown of motor connector wires |
1 |
0.47% |
| Risks of Polymer Leaks During Implantation |
1 |
0.47% |
| Inaccuracies in deep brain stimulation (DBS) procedures |
1 |
0.47% |
| Detachment of the tip |
1 |
0.47% |
| Displaying the reversed image |
1 |
0.47% |
| Fully and partially blocked needles |
1 |
0.47% |
| Malfunction leading to potential entry of water into the airway |
1 |
0.47% |
| Incorrect insulin dosage |
1 |
0.47% |
| Mechanical ventilation loss |
1 |
0.47% |
| Inaccurate oxygen values |
1 |
0.47% |
| Valve displacement |
1 |
0.47% |
