Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,151–3,200 of 8,689
- Class II
Medical Device Recall · August 29, 2025
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas sWound dressing may have foreign matter on the product.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, iPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includinPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includinPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, incluPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
- Class II
Medical Device Recall · August 29, 2025
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.
- Class II
Medical Device Recall · August 29, 2025
Fresenius Medical Care Holdings, Inc.
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includingPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), PrIV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includingPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includinPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includingPotential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Class II
Medical Device Recall · August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593IV sets may leak.
- Class II
Medical Device Recall · August 29, 2025
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
- Class II
Medical Device Recall · August 28, 2025
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Connectom.X. Model Number: 11371480.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Prisma. Model Number: 10849582.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot. Model Number: 10684333.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class II
Medical Device Recall · August 28, 2025
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
BIOGRAPH One (DE). Model Number: 11689172.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description:A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
Biograph mMR. Model Number: 10433372.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Vida Fit. Model Number: 11410481.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Skyra fit. Model Number: 10849580.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Verio. Model Number: 10276755.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class II
Medical Device Recall · August 28, 2025
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class II
Medical Device Recall · August 27, 2025
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
- Class II
Medical Device Recall · August 26, 2025
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- Class II
Medical Device Recall · August 26, 2025
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A,Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
- Class II
Medical Device Recall · August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- Class II
Medical Device Recall · August 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.