Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 3521–3540 of 38,428 recalls

October 21, 2024· Baxter Healthcare Corporation

Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short

The Issue: Baxter is aware of several recalls by other

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 21, 2024· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain

The Issue: A manufacturing defect causes Atellica CH Reaction Ring

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 21, 2024· Biomet, Inc.

Recalled Item: JuggerLoc/ToggleLoc 2.9mm Drill Guide

The Issue: Firm received complaints reporting that guides were warped

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 21, 2024· Baxter Healthcare Corporation

Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

The Issue: Baxter is aware of several recalls by other

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 21, 2024· Baxter Healthcare Corporation

Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

The Issue: Baxter is aware of several recalls by other

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 21, 2024· Baxter Healthcare Corporation

Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

The Issue: Baxter is aware of several recalls by other

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 21, 2024· Baxter Healthcare Corporation

Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp

The Issue: Baxter is aware of several recalls by other

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 21, 2024· Karl Storz Endoscopy

Recalled Item: Irrigation Tubing for KARL STORZ Endomat Select UP210

The Issue: Due to improper labeling of products. An intended

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 21, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Iris Scissors

The Issue: Tip protector may fall off within the packaging,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 18, 2024· HUMAN MED AG

Recalled Item: human med Biofill Infiltration Cannula

The Issue: The cannula tubes do not comply with the

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 18, 2024· LivaNova Deutschland GmbH

Recalled Item: Essenz HLM (Heart-Lung Machine)

The Issue: Heart-Lung Machine GUI touchscreen may go dark for

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 18, 2024· Zyno Medical LLC

Recalled Item: Z-800 Infusion System. Model/Catalog Number: Z-800

The Issue: for the battery to deplete over time

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 17, 2024· Abbott Medical

Recalled Item: Abbott Navitor Transcatheter Aortic Heart Valve

The Issue: A manufacturing error resulting in acceptance of valves

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 17, 2024· Abbott Medical

Recalled Item: Abbott Navitor Transcatheter Aortic Heart Valve

The Issue: A manufacturing error resulting in acceptance of valves

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 17, 2024· Roche Diagnostics Operations, Inc.

Recalled Item: cobas HCYS

The Issue: Abnormal calibration signals and control recovery issues on

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 17, 2024· Abbott Medical

Recalled Item: Abbott Navitor Titan

The Issue: A manufacturing error resulting in acceptance of valves

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 17, 2024· Abbott Medical

Recalled Item: Abbott Navitor

The Issue: A manufacturing error resulting in acceptance of valves

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 17, 2024· Abbott Medical

Recalled Item: Abbot Navitor

The Issue: A manufacturing error resulting in acceptance of valves

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 16, 2024· CORNEAT VISION, LTD.

Recalled Item: CorNeat EverPatch

The Issue: Retroactive; Due to complaints, labeling correction for permanent

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 16, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL

The Issue: The connectors may not allow catheters to be

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing