3B Medical, Inc. recalls Brand Name: 3B Medical

The devices were inadvertently shipped after their expiration date.

On November 27, 2024 3B Medical Inc., dba React Health issued a "Urgent: Medical Device Recall" notification to affected consignees via Email. On 12/5/2024 React Health provided an updated letter to affected consignees via USPS certified Mail. In addition to making the aware of the issue, React Health asked consignees to take the following steps: 1. Please confirm receipt of this notification letter by returning the enclosed Customer Response Form to 3B Medical, Inc., within 7 days, by US Mail or via attachment to e-Mail sent to christopher.wood@reacthealth.com. 2. Confirm that end users and customers have been contacted and instructed to stop using the affected cannulas. 3. Return the affected product to 3B Medical, Inc. dba React Health. 3B Medical, Inc., dba React Health will provide FedEx return labels or arrange for the shipping of the devices you have to return. 4. 3B Medical, Inc., dba React Health, has inventory to replace your devices and will place $0 orders to replace all the devices that were shipped to you expired. 5. Please acknowledge receipt of this notification and respond via the enclosed Customer Response Form within 7 days of receipt. 6. Adverse events, reactions. or quality issues experienced with the use of these devices may be reported to us at 3B Medical, Inc., dba React Health or via the FDA s MedWatch Adverse Event Reporting program.

• FDA enforcement recordOfficial FDA database entry for Z-0828-2025
• FDA device classification · BZBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find 3B Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.