Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 2,451–2,500 of 7,959

• Medical Device Recall · August 29, 2025

  Baxter Healthcare Corporation

  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610

  IV sets may leak.

  Class II

• Medical Device Recall · August 29, 2025

  Baxter Healthcare Corporation

  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 2H8603

  IV sets may leak.

  Class II

• Medical Device Recall · August 29, 2025

  Northeast Scientific Inc.

  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, inclu

  Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

  Class II

• Medical Device Recall · August 29, 2025

  Northeast Scientific Inc.

  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, including

  Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

  Class II

• Medical Device Recall · August 29, 2025

  Baxter Healthcare Corporation

  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 2C8519

  IV sets may leak.

  Class II

• Medical Device Recall · August 29, 2025

  Baxter Healthcare Corporation

  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 2C8593

  IV sets may leak.

  Class II

• Medical Device Recall · August 28, 2025

  Boston Scientific Corporation

  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 II

• 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 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

  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

  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

  Vantive US Healthcare LLC

  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 II

• 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 I

• Medical Device Recall · August 28, 2025

  Dexcom, Inc.

  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 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 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

  Howmedica Osteonics Corp.

  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 II

• 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 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

  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 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 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 27, 2025

  Vision RT Ltd

  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

  W L Gore & Associates, Inc.

  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 Implant Co., Ltd.

  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

  OSSTEM Implant Co., Ltd.

  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 Implant Co., Ltd.

  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.

  Class II

• Medical Device Recall · August 25, 2025

  LeMaitre Vascular, Inc.

  Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or repla

  Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

  Class II

• Medical Device Recall · August 22, 2025

  Sonesta Medical AB

  Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the u

  Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

  Class II

• Medical Device Recall · August 22, 2025

  CooperVision, Inc.

  Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Dai

  One lot manufactured with an invalid sterilization cycle.

  Class II

• Medical Device Recall · August 22, 2025

  CooperVision, Inc.

  Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable W

  One lot manufactured with an invalid sterilization cycle.

  Class II

• Medical Device Recall · August 22, 2025

  CooperVision, Inc.

  MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Bli

  One lot manufactured with an invalid sterilization cycle.

  Class II

• Medical Device Recall · August 22, 2025

  GE Medical Systems, LLC

  MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

  If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

  Class II

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT CG4+ cartridge (white). List Number: 03P85-25.

  Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Bard Peripheral Vascular Inc

  Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop

  Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT EG6+ cartridge. List Number: 03P77-25.

  Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT EG7+ cartridge. List Number: 03P76-25.

  Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Medline Industries, LP

  Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

  The kits contain certain lots of cannula products where the catheter may not retain its shape.

  Class I

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

  Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  PROPONENT DR SL (Model L201)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  MicroSurgical Technology Inc

  MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

  An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

  Class II