Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 2,751–2,800 of 7,959
- Class I
Medical Device Recall · July 10, 2025
All-round Joystick R-net Light. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
- Class I
Medical Device Recall · July 10, 2025
IDM-MULTI-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
- Class III
Medical Device Recall · July 10, 2025
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
- Class I
Medical Device Recall · July 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
- Class I
Medical Device Recall · July 10, 2025
IDM-MICRO-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
- Class II
Medical Device Recall · July 10, 2025
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
- Class I
Medical Device Recall · July 10, 2025
Micro Joystick R-net. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
- Class I
Medical Device Recall · July 9, 2025
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult RePotential for the manometer port being blocked rendering the manometer non-functional.
- Class II
Medical Device Recall · July 9, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.
- Class II
Medical Device Recall · July 9, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment oKnee implants contain incorrect labeling (size and/or side incorrect)
- Class II
Medical Device Recall · July 9, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment oKnee implants contain incorrect labeling (size and/or side incorrect)
- Class I
Medical Device Recall · July 9, 2025
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
- Class I
Medical Device Recall · July 8, 2025
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back CheckInfusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
- Class II
Medical Device Recall · July 8, 2025
MEDLINE INDUSTRIES, LP - Northfield
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of compoAffected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
- Class II
Medical Device Recall · July 8, 2025
Boston Scientific Neuromodulation Corporation
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.
- Class II
Medical Device Recall · July 8, 2025
Becton, Dickinson and Company, BD Bio Sciences
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVDControl kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
- Class I
Medical Device Recall · July 8, 2025
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsInfusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
- Class II
Medical Device Recall · July 8, 2025
Boston Scientific Neuromodulation Corporation
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant ManualResistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.
- Class II
Medical Device Recall · July 8, 2025
Becton, Dickinson and Company, BD Bio Sciences
BD Trucount Controls, 30 Test - REF: 340335Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
- Class I
Medical Device Recall · July 7, 2025
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
- Class II
Medical Device Recall · July 7, 2025
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
- Class III
Medical Device Recall · July 3, 2025
Mini Multi TEE Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S4-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S7-2t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
mC7-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
X3-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S5-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C9-3v Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
TRANSDUCER L12-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C5-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
V9-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
X8-2t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
BP10-5ec Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L8-4 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
D2TCD Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C9-4 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L10-4LAP Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C10-4ec Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S4-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L11-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
L17-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
OMNI III TEE Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C9-5ec Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C6-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S7-3t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
V6-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
S12-4 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
C9-3io Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class III
Medical Device Recall · July 3, 2025
X5-1c Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Class II
Medical Device Recall · July 3, 2025
Orascoptic Superior Visualization Custom loupes with Dragonfly framesDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.