Medical Device Recalls

7,870 medical device recalls from federal enforcement feeds.

Showing 301–350 of 7,870

• Medical Device Recall · April 21, 2026

  ARROW INTERNATIONAL, LLC

  Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CAT

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

  Class I

• Medical Device Recall · April 21, 2026

  Medtronic Perfusion Systems

  Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

  Certain lots of product have the potential for a sterile barrier breach.

  Class II

• Medical Device Recall · April 21, 2026

  Medtronic Perfusion Systems

  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter

  Certain lots of product have the potential for a sterile barrier breach.

  Class II

• Medical Device Recall · April 21, 2026

  ARROW INTERNATIONAL, LLC

  Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

  Class I

• Medical Device Recall · April 21, 2026

  ARROW INTERNATIONAL, LLC

  Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

  Class I

• Medical Device Recall · April 20, 2026

  Shimadzu Medical Systems

  Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Rad

  Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

  Class II

• Medical Device Recall · April 20, 2026

  GE Medical Systems, LLC

  Allia IGS Pulse angiographic X-ray system

  GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

  Class II

• Medical Device Recall · April 20, 2026

  GE Medical Systems, LLC

  Allia Moveo angiographic X-ray system

  GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

  Class II

• Medical Device Recall · April 20, 2026

  GE Medical Systems, LLC

  Allia IGS 7 Pulse angiographic X-ray system

  GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

  Class II

• Medical Device Recall · April 20, 2026

  Staar Surgical AG

  Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter

  Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

  Class II

• Medical Device Recall · April 20, 2026

  GE Medical Systems, LLC

  Allia IGS 5 Pulse angiographic X-ray system

  GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

  Class II

• Medical Device Recall · April 20, 2026

  GE Medical Systems, LLC

  Allia IGS 3 Pulse angiographic X-ray system

  GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

  Class II

• Medical Device Recall · April 20, 2026

  Abiomed, Inc.

  Automated Impella Controller (AIC); Product Code: 0042-0000-US;

  A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

  Class I

• Medical Device Recall · April 16, 2026

  The Binding Site Group, Ltd.

  Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qua

  It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.

  Class II

• Medical Device Recall · April 15, 2026

  Fresh Roast Systems Inc

  Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

  A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.

  Class II

• Medical Device Recall · April 15, 2026

  Covidien, LP

  Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

  The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

  Class II

• Medical Device Recall · April 15, 2026

  Covidien LLC

  COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Trache

  Due to customer complaint regarding incorrect display box labeling.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k)

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063,

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458,

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Dexcom, Inc.

  Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: De

  A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Dexcom, Inc.

  Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dex

  A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K2

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Philips North America

  Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

  The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

  Class II

• Medical Device Recall · April 14, 2026

  Dexcom, Inc.

  Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description

  A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

  Class II

• Medical Device Recall · April 13, 2026

  Jolife AB

  LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875

  Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

  Class II

• Medical Device Recall · April 13, 2026

  HF Acquisition Co LLC

  Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Descriptio

  Due to incorrect incubation process being performed on product.

  Class II

• Medical Device Recall · April 13, 2026

  HF Acquisition Co LLC

  Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Descriptio

  Due to incorrect incubation process being performed on product.

  Class II

• Medical Device Recall · April 13, 2026

  O&M HALYARD INC

  Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

  Nitrile Exam Glove failed to meet specifications chemical permeation performance.

  Class II

• Medical Device Recall · April 13, 2026

  Physio-Control, Inc.

  LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 9

  Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

  Class II

• Medical Device Recall · April 10, 2026

  Integra LifeSciences Corp. (NeuroSciences)

  Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diver

  Out-of-specification endotoxin result that did not meet the acceptance criteria.

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

  Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.

  Class II