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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 1–20 of 1,000 recalls

Class IITerminated

SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system

Surgical Theater Inc

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

September 16, 2025 · DeviceView details →
Class IITerminated

Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

Insightra Medical Inc

Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.

July 19, 2025 · DeviceView details →
Class IITerminated

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Numed Inc

Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

April 21, 2025 · DeviceView details →
Class IITerminated

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

Centers For Disease Control and Prevention

The H5b component may fail to amplify, resulting in an inconclusive result.

April 26, 2024 · DeviceView details →
Class IITerminated

CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

Cardinal Health 200, LLC

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

December 21, 2023 · DeviceView details →
Class IITerminated

Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517

Cardinal Health 200, LLC

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

December 21, 2023 · DeviceView details →
Class IITerminated

Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516

Cardinal Health 200, LLC

The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

December 21, 2023 · DeviceView details →
Class IITerminated

Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Vortex Surgical Inc.

Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

December 18, 2023 · DeviceView details →
Class ITerminated

regard Operative LAP, Item Number 800943001; surgical convenience kit

ROi CPS LLC

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

December 18, 2023 · DeviceView details →
Class ITerminated

Regard Dressing change kit, Item Number 800026006

ROi CPS LLC

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

November 20, 2023 · DeviceView details →
Class IITerminated

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Abiomed, Inc.

Pump not detected as connected to controller due to software issue.

October 10, 2023 · DeviceView details →
Class IITerminated

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

Abiomed, Inc.

Pump not detected as connected to controller due to software issue.

October 10, 2023 · DeviceView details →
Class ITerminated

Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system

Asensus Surgical Inc

Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.

September 15, 2023 · DeviceView details →
Class IITerminated

NexGen Precoat Stemmed Tibial Plate Size 5

Zimmer, Inc.

Device outer packaging was incorrectly labeled.

May 19, 2023 · DeviceView details →
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