STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0488-2023.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0488-2023.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Stradis Medical, Llc Dba Stradis Healthcare or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0488-2023.
Stradis Medical, LLC dba Stradis Healthcare
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Stradis Medical, Llc Dba Stradis Healthcare Recall FAQ
Stradis Medical, Llc Dba Stradis Healthcare is the subject of a medical implants safety report: STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray. The notice was published on November 2, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 20 units are potentially affected.