SteriPack Sterile Polyester Spun Swabs (25 units/Pack)-… recallZ-1970-2023 · LumiraDx · initiated Apr 25, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from LumiraDx or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Process control

What the company is doing

LumiraDx issued on 25 April 2023 via email electronic Cover Letter and Urgent Product Recall Notice with an attestation form to document product destruction at their facility. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lot of swabs " Remove from your stock any remaining affected kits of swabs. " Destroy all stock of affected swabs " Indicate the number of packs that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected swabs in your inventory. " Report any issues or adverse events with using the affected swabs to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product after receipt of the attestation form. Please contact [email protected] to arrange overnight shipment. Please complete and return the enclosed product destruction and attestation form to LumiraDx as soon as possible. If you have any questions, contact LumiraDx Technical Services at [email protected] or 1-888-586-4721 option 1

Recall details

Recall number: Z-1970-2023
Status: Open, Classified
Initiated by the company: Apr 25, 2023
Posted by the FDA: Jun 15, 2023
Recalling firm: LumiraDx
Quantity: 1003 kits
Product code: KXG
Distribution: US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sterile Polyester Spun Swab 25 Pack 60566
Steripack (usa) Limited LLC · Applicator, Absorbent Tipped, Sterile
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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