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FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 261–280 of 1,000 recalls

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 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 →

Class IIOngoing

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

Milestone S.R.L.

There is a possibility of reagent leakage from the specimen container.

March 9, 2026 · DeviceView details →

Class IIOngoing

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

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, Central Line Dressing Kit, Model/Catalog Number: 2717H

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, IV Start Kit, Model/Catalog Number: 3131

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, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

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

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 vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

Clinical Innovations, LLC

Due to complaints of device breakage at the traction force gauge to handle joint.

March 9, 2026 · DeviceView details →

Class IIOngoing

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 Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

XTANT Medical Holdings, Inc

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

March 9, 2026 · DeviceView details →

Class IIOngoing

Philips Spectral CT on Rails. Model Number: 728334.

PHILIPS MEDICAL SYSTEMS

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.

March 7, 2026 · DeviceView details →

Class IIOngoing

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Integra LifeSciences Corp. (NeuroSciences)

Software issue that renders the touch screen unresponsive.

March 6, 2026 · DeviceView details →

Class IIOngoing

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. The product has two peak emission wavelengths at 274 nm and 397 nm.

Uvlizer c/o RAIS INTERNATIONAL LLC

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.

March 6, 2026 · DeviceView details →

Class IIOngoing

The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

Uvlizer c/o RAIS INTERNATIONAL LLC

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.

March 6, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

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