Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 3,451–3,500 of 8,689

Medical Device Recall · July 14, 2025
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK,
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · July 14, 2025
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · July 14, 2025
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CA
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · July 14, 2025
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Laryngoscope handles may not illuminate as intended.
Class I
Medical Device Recall · July 11, 2025
Remel, Inc
Strep Selective II Agar, Product Number R01859
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-
Laryngoscope handles may not illuminate as intended.
Class I
Medical Device Recall · July 11, 2025
Remel, Inc
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II
Medical Device Recall · July 11, 2025
Onkos Surgical, Inc.
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller
Laryngoscope handles may not illuminate as intended.
Class I
Medical Device Recall · July 11, 2025
ICU Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Laryngoscope handles may not illuminate as intended.
Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Laryngoscope handles may not illuminate as intended.
Class I
Medical Device Recall · July 11, 2025
Remel, Inc
Blood/EMB, Levine 100/PK, Product Number R02041
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II
Medical Device Recall · July 11, 2025
Onkos Surgical, Inc.
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II
Medical Device Recall · July 11, 2025
Onkos Surgical, Inc.
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II
Medical Device Recall · July 11, 2025
Remel, Inc
Blood/MacConkey Biplate 100/PK, Product Number R02049
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Laryngoscope handles may not illuminate as intended.
Class I
Medical Device Recall · July 10, 2025
mo-Vis BVBA
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 I
Medical Device Recall · July 10, 2025
mo-Vis BVBA
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 10, 2025
mo-Vis BVBA
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 I
Medical Device Recall · July 10, 2025
mo-Vis BVBA
Multi 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 10, 2025
Beckman Coulter, Inc.
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.
Class II
Medical Device Recall · July 10, 2025
mo-Vis BVBA
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
mo-Vis BVBA
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
CareFusion 303, Inc.
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-1
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
Class III
Medical Device Recall · July 10, 2025
Biofire Defense
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 II
Medical Device Recall · July 9, 2025
Encore Medical, LP
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 o
Knee implants contain incorrect labeling (size and/or side incorrect)
Class II
Medical Device Recall · July 9, 2025
Encore Medical, LP
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 o
Knee implants contain incorrect labeling (size and/or side incorrect)
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
B BRAUN MEDICAL INC
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 9, 2025
Ambu Inc.
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 Re
Potential for the manometer port being blocked rendering the manometer non-functional.
Class I
Medical Device Recall · July 8, 2025
Becton, Dickinson and Company, BD Bio Sciences
BD Trucount Controls, 30 Test - REF: 340335
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
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 compo
Affected 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
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Resistance 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
CareFusion 303, Inc.
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Infusion 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 I
Medical Device Recall · July 8, 2025
CareFusion 303, Inc.
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 Check
Infusion 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 I
Medical Device Recall · July 8, 2025
Boston Scientific Neuromodulation Corporation
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Wire 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, IVD
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
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 II
Medical Device Recall · July 7, 2025
Boston Scientific Corporation
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310
Certain 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 I
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X3-1 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X8-2t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X11-4t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
3D6-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L9-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
XL14-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C8-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
mC12-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III