Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,601–3,650 of 8,689
- Class I
Medical Device Recall · June 30, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration.
- Class II
Medical Device Recall · June 30, 2025
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
- Class II
Medical Device Recall · June 30, 2025
Ingenia 1.5T S Model Number (REF): 781347;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class I
Medical Device Recall · June 30, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration.
- Class II
Medical Device Recall · June 27, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LKWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Class II
Medical Device Recall · June 27, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Class II
Medical Device Recall · June 27, 2025
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.Device does not comply with the labeling requirements of international standard IEC 60601-1.
- Class II
Medical Device Recall · June 27, 2025
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterileAffected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
- Class II
Medical Device Recall · June 26, 2025
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
- Class II
Medical Device Recall · June 26, 2025
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
- Class II
Medical Device Recall · June 26, 2025
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identificaPotential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
- Class I
Medical Device Recall · June 26, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
- Class II
Medical Device Recall · June 25, 2025
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provideDue to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
- Class II
Medical Device Recall · June 25, 2025
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
- Class II
Medical Device Recall · June 25, 2025
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH InstruDue to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
- Class II
Medical Device Recall · June 25, 2025
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Class II
Medical Device Recall · June 25, 2025
MicroScan Neg MIC 3J REF C54814Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- Class II
Medical Device Recall · June 25, 2025
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Class II
Medical Device Recall · June 25, 2025
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Class II
Medical Device Recall · June 25, 2025
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
- Class II
Medical Device Recall · June 25, 2025
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Class II
Medical Device Recall · June 25, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Class II
Medical Device Recall · June 25, 2025
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Class II
Medical Device Recall · June 24, 2025
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx OnlyDue to manufacturing error, digital analog rotational feature is 180 degrees off.
- Class II
Medical Device Recall · June 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.Potential for external cassette leaks
- Class II
Medical Device Recall · June 24, 2025
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SPA 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
- Class II
Medical Device Recall · June 24, 2025
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.Potential for external cassette leaks
- Class II
Medical Device Recall · June 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.Potential for external cassette leaks
- Class II
Medical Device Recall · June 24, 2025
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.Potential for external cassette leaks
- Class II
Medical Device Recall · June 23, 2025
BD COR System Software. Model Number: 444829.Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
- Class II
Medical Device Recall · June 23, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting SystemsThe DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
- Class I
Medical Device Recall · June 23, 2025
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equDue to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
- Class I
Medical Device Recall · June 23, 2025
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS)Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
- Class I
Medical Device Recall · June 23, 2025
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, PackA potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
- Class II
Medical Device Recall · June 23, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting SystemsThe DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
- Class II
Medical Device Recall · June 23, 2025
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPNBedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class I
Medical Device Recall · June 20, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAXCertain Spectrum infusion pumps may have an incorrect version of software.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic ResonanceGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class I
Medical Device Recall · June 20, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2Certain Spectrum infusion pumps may have an incorrect version of software.
- Class II
Medical Device Recall · June 20, 2025
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
GE Signa Voyager, Nuclear Magnetic Resonance Imaging SystemGE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Class II
Medical Device Recall · June 20, 2025
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.