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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 301–320 of 1,000 recalls

Class IIOngoing

ARTIS Pheno VE30A and VE40A, Model 10849000

Siemens Medical Solutions USA, Inc

During 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.

March 12, 2026 · DeviceView details →
Class IIOngoing

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

Healthmark Industries Co., Inc.

Product does not have FDA clearance.

March 12, 2026 · DeviceView details →
Class IIOngoing

LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

Linkbio Corp.

The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

March 12, 2026 · DeviceView details →
Class IIOngoing

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

Medtronic, Inc.

ventricular fibrillation (VF) 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.

March 11, 2026 · DeviceView details →
Class IIOngoing

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 Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

Windstone Medical Packaging, Inc.

The 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).

March 11, 2026 · DeviceView details →
Class IIOngoing

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)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

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 UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied.

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

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 Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. The Arrow Combined Spinal Anesthesia and Epidural Catheterization products permit access to subarachnoid and epidural spaces. The Arrow Single Shot Epidural product permits access to the epidural space..

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

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 venous access and catheter introduction to the central circulation.

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Windstone Medical Packaging, Inc.

The 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).

March 11, 2026 · DeviceView details →
Class IIOngoing

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 protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

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 protection device covers the needle after use to help prevent needle sticks.

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IIOngoing

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

Windstone Medical Packaging, Inc.

The 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).

March 11, 2026 · DeviceView details →
Class IIOngoing

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-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

ARROW INTERNATIONAL, LLC

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

March 11, 2026 · DeviceView details →
Class IOngoing

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Intuitive Surgical, Inc.

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

March 11, 2026 · DeviceView details →
Class IIOngoing

Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

An 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.

March 10, 2026 · DeviceView details →
Class IIOngoing

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Siemens Medical Solutions USA, Inc

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.

March 10, 2026 · DeviceView details →
Class IIOngoing

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

March 9, 2026 · DeviceView details →
Class IIOngoing

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

LSL Healthcare Inc.

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

March 9, 2026 · DeviceView details →
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