Medical Device Recalls
RSS ↗8,553 medical device recalls from federal enforcement feeds.
Showing 1,251–1,300 of 8,553
- Class I
Medical Device Recall · March 13, 2026
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Class I
Medical Device Recall · March 13, 2026
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Class II
Medical Device Recall · March 13, 2026
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent TCustomers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- Class II
Medical Device Recall · March 13, 2026
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- Class II
Medical Device Recall · March 13, 2026
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent TuCustomers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- Class I
Medical Device Recall · March 13, 2026
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Class II
Medical Device Recall · March 12, 2026
Stryker Sustainability Solutions
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port SingleDue to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
- Class II
Medical Device Recall · March 12, 2026
Siemens Medical Solutions USA, Inc
ARTIS Pheno VE30A and VE40A, Model 10849000During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- Class II
Medical Device Recall · March 12, 2026
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
- Class II
Medical Device Recall · March 12, 2026
B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for PlacentalCustomers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.
- Class II
Medical Device Recall · March 12, 2026
iLet Bionic Pancreas, REF: BB1001insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
- Class II
Medical Device Recall · March 12, 2026
Healthmark Industries Co., Inc.
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styleProduct does not have FDA clearance.
- Class I
Medical Device Recall · March 12, 2026
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
- Class II
Medical Device Recall · March 11, 2026
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural CatheDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Windstone Medical Packaging, Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994AThe product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Class II
Medical Device Recall · March 11, 2026
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venousDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide proDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Windstone Medical Packaging, Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Class II
Medical Device Recall · March 11, 2026
Windstone Medical Packaging, Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Class I
Medical Device Recall · March 11, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
- Class II
Medical Device Recall · March 11, 2026
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-LumenDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protecDue to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDIDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 11, 2026
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
- Class II
Medical Device Recall · March 11, 2026
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous AcceDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Class II
Medical Device Recall · March 10, 2026
Siemens Medical Solutions USA, Inc
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
- Class II
Medical Device Recall · March 10, 2026
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USAn internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925HMedical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717HMedical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced BProducts were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717JMedical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
Siemens Medical Solutions USA, Inc
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemDuring patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Class II
Medical Device Recall · March 9, 2026
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuumDue to complaints of device breakage at the traction force gauge to handle joint.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
Siemens Medical Solutions USA, Inc
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray systemDuring patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Class II
Medical Device Recall · March 9, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- Class II
Medical Device Recall · March 9, 2026
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SSThere is a possibility of reagent leakage from the specimen container.
- Class II
Medical Device Recall · March 7, 2026
Philips Spectral CT on Rails. Model Number: 728334.Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
- Class II
Medical Device Recall · March 6, 2026
Integra LifeSciences Corp. (NeuroSciences)
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.Software issue that renders the touch screen unresponsive.
- Class II
Medical Device Recall · March 6, 2026
Uvlizer c/o RAIS INTERNATIONAL LLC
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
- Class II
Medical Device Recall · March 6, 2026
Uvlizer c/o RAIS INTERNATIONAL LLC
The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3.In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference PProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Class II
Medical Device Recall · March 5, 2026
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersCalibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
- Class II
Medical Device Recall · March 5, 2026
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.