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 4461–4480 of 38,428 recalls

July 16, 2024· Philips Respironics, Inc.

Recalled Item: Trilogy Evo Universal Ventilator

The Issue: Firm has released a mandatory software update Version

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

Class I — Serious Health HazardOngoing
July 16, 2024· Philips Respironics, Inc.

Recalled Item: Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo

The Issue: Firm has released a mandatory software update Version

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

Class I — Serious Health HazardOngoing
July 15, 2024· Omnia Medical

Recalled Item: TiBrid Stand Alone Intervertebral Body Fusion Device

The Issue: Failure of fusion system instruments in the field

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

Class II — Potential Health HazardOngoing
July 15, 2024· Omnia Medical

Recalled Item: TiBrid Stand Alone Intervertebral Body Fusion Device

The Issue: Failure of fusion system instruments in the field

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Name: TOTAL PLUS

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG...

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT SAFETY SLIT SB

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number:

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Name: TOTALPLUS

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing
July 15, 2024· Alcon Research LLC

Recalled Item: Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG

The Issue: Alcon has detected an increase in complaint reports

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

Class II — Potential Health HazardOngoing