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
LumiraDx is recalling sterile nasal swabs that could break inside the nasal cavity, potentially causing injury or requiring medical intervention. This recall affects swabs with specific lot numbers that expired by October 2023.
The swabs fail sterile testing and may break during use in the nasal cavity. If broken inside the nasal cavity, they could cause injury or require medical intervention to remove the broken swab.
Healthcare professionals using these swabs for nasal sample collection are most at risk. Patients receiving nasal swabs from affected lots may experience injury.
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.
Look for individual swab lot number 86445 or pack lot number 85438 on the packaging.
If you have the recalled lot numbers, discard the swabs immediately to avoid injury risk.
The swabs fail sterile testing and may break during use in the nasal cavity, potentially causing injury or requiring medical intervention.
Pack lot number 85438 and individual swab lot number 86445 with expiration date 28-Oct-2023.
Check for catalog number 60566RevB, GTIN-DI 00850027193205, or lot numbers 85438 (pack) and 86445 (individual swab).
We’ve drafted a message you can send LumiraDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1970-2023 — LumiraDx LumiraDx Hello, I own a LumiraDx that is covered by recall Z-1970-2023 from LumiraDx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
