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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 321–340 of 1,000 recalls

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 →

Class IIOngoing

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

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 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 G50792

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 Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807.

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 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 Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.

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 Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

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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