Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 3,951–4,000 of 8,689

Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Spectral Instruments Inc
Ami HTX.
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Class II
Medical Device Recall · May 12, 2025
BD SWITZERLAND SARL
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class II
Medical Device Recall · May 12, 2025
BD SWITZERLAND SARL
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class II
Medical Device Recall · May 12, 2025
Dexcom, Inc.
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Class I
Medical Device Recall · May 12, 2025
BD SWITZERLAND SARL
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed M
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class II
Medical Device Recall · May 12, 2025
Dexcom, Inc.
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Class I
Medical Device Recall · May 12, 2025
HemoCue AB
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
Class II
Medical Device Recall · May 12, 2025
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
Class II
Medical Device Recall · May 12, 2025
Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Class I
Medical Device Recall · May 12, 2025
Dexcom, Inc.
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Class I
Medical Device Recall · May 12, 2025
Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
Class II
Medical Device Recall · May 12, 2025
Dexcom, Inc.
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Class I
Medical Device Recall · May 12, 2025
BD SWITZERLAND SARL
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class II
Medical Device Recall · May 12, 2025
BD SWITZERLAND SARL
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class II
Medical Device Recall · May 9, 2025
Barco N.V.
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
Class II
Medical Device Recall · May 9, 2025
Philips Respironics, Inc.
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilat
This device does not indicate for use in patients with respiratory failure.
Class I
Medical Device Recall · May 9, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Produc
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Class II
Medical Device Recall · May 9, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Class II
Medical Device Recall · May 9, 2025
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
This device does not indicate for use in patients with respiratory failure.
Class I
Medical Device Recall · May 9, 2025
Philips Respironics, Inc.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
This device does not indicate for use in patients with respiratory failure.
Class I
Medical Device Recall · May 9, 2025
Baxter Healthcare Corporation
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Class II
Medical Device Recall · May 9, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions);
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Class II
Medical Device Recall · May 8, 2025
CareFusion 303, Inc.
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES /
Antivirus software was not consistently installed on impacted devices during the implementation process.
Class II
Medical Device Recall · May 8, 2025
BALT USA, LLC
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 008100685
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II
Medical Device Recall · May 8, 2025
CareFusion 303, Inc.
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352]
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Class II
Medical Device Recall · May 8, 2025
BALT USA, LLC
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II
Medical Device Recall · May 8, 2025
Ohio Medical Corporation
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Class II
Medical Device Recall · May 7, 2025
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
Class II
Medical Device Recall · May 7, 2025
LUMITHERA INC
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration C
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Class III
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
Medtronic MiniMed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Class II
Medical Device Recall · May 7, 2025
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Class II
Medical Device Recall · May 7, 2025
MicroAire Surgical Instruments, LLC
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: Sma
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Class II
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems u
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Descripti
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Copan WASP
PhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
Class II
Medical Device Recall · May 6, 2025
Baxter Healthcare Corporation
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E1
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Class II
Medical Device Recall · May 6, 2025
Hardy Diagnostics
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TF
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 5, 2025
Dexcom, Inc.
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Class II
Medical Device Recall · May 5, 2025
Beckman Coulter, Inc.
Access Testosterone assay, Catalog Number 33560
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
Class II
Medical Device Recall · May 5, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-se
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Class II