Use cautionMedical device recall · FDA · Published April 25, 2023
LumiraDx SteriPack Swabs May Break in Nasal Cavity Causing Injury
LumiraDx recalls 25-unit packs of SteriPack sterile swabs that may break in nasal cavities, causing injury or requiring medical removal. Recalled lots expired by Oct 2023.
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
Take action
Contact the company
📍Recalling firmLumiraDx221 Crescent St · Waltham, MA 02453-3475
“LumiraDx SteriPack Swabs May Break in Nasal Cavity Causing Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58499-lumiradx-steripack-swabs-may-break-in-nasal-cavity-causing-injury. Based on FDA recall #Z-1970-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2023%22&limit=1).
The FDA announced on April 25, 2023, that LumiraDx is recalling SteriPack Sterile Polyester Spun Swabs due to potential breakage. Owners should stop using the product immediately.
The swabs fail post-sterilization cantilever testing and may be more susceptible to breakage. If a swab breaks in the nasal cavity, it may cause injury or require medical intervention to remove part of the swab.
Context
GovInfoNow's records show LumiraDx has issued four other recalls since January 11, 2021. Other recent recalls of similar products include Boston Scientific EndoVive Safety PEG Kit Recall (February 10, 2026), Covidien Surgipro SP-623 Sutures (June 24, 2026), and Medline Convenience Kits Recall (June 12, 2026).
How to tell if you have this one
Check for the catalog number 60566RevB, GTIN-DI 00850027193205, or lot numbers 85438 (pack) and 86445 (individual swab). Swabs with expiration date 28-Oct-2023 are affected.
Brand
LumiraDx
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Swab Lot Numbers
Look for individual swab lot number 86445 or pack lot number 85438 on the packaging.
Discard Swabs
If you have the recalled lot numbers, discard the swabs immediately to avoid injury risk.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1970-2023 (April 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1970-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.