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 21241–21260 of 38,428 recalls

April 13, 2018· TriMed Inc.

Recalled Item: Nitinol Staple

The Issue: During a retrospective review of sterilization records, TriMed

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

Class II — Potential Health HazardTerminated
April 13, 2018· TriMed Inc.

Recalled Item: Nitinol Staple

The Issue: During a retrospective review of sterilization records, TriMed

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

Class II — Potential Health HazardTerminated
April 13, 2018· Coltene Whaledent Inc

Recalled Item: Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs)

The Issue: The products are labeled with an incorrect product

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

Class II — Potential Health HazardTerminated
April 12, 2018· Vitalgo Inc.

Recalled Item: VitalGo Total Lift Bed VG-TLB425T-TQR

The Issue: for unintentional movement of the support surface

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

Class II — Potential Health HazardTerminated
April 11, 2018· Stryker Neurovascular

Recalled Item: FlowGate2 Balloon Guide Catheter

The Issue: There may be product manufactured with the outer

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

Class II — Potential Health HazardTerminated
April 11, 2018· Becton Dickinson & Company

Recalled Item: The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is

The Issue: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate

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

Class II — Potential Health HazardTerminated
April 11, 2018· Becton Dickinson & Company

Recalled Item: The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is

The Issue: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate

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

Class II — Potential Health HazardTerminated
April 11, 2018· Becton Dickinson & Company

Recalled Item: The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is

The Issue: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: 4Fr. Catheter Clamp with Fastener

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: 8Fr. Catheter Clamp with Fastener

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Maximal Barrier Drape

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous...

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R)...

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Peel Away Sheath over Dilator

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Maximal Barrier Drape

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue...

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Radial Arterial Access Kit

The Issue: Product sterility may be compromised due to unsealed

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

Class II — Potential Health HazardTerminated