Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample Recalled by LumiraDx Due to Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and...

Date: April 25, 2023
Company: LumiraDx
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LumiraDx directly.

Affected Products

SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

Quantity: 1003 kits

Why Was This Recalled?

Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LumiraDx

LumiraDx has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report