SteriPack Sterile Polyester Spun Swabs — Class II medical device recall Z-1970-2023
Ongoing recall by LumiraDx, reported 2023-06-21, distributed nationwide. Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If t
| Recall number | Z-1970-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LumiraDx, Waltham, MA, United States |
| Recall initiated | 2023-04-25 |
| Classified | 2023-06-15 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,003 kits |
| Reason classes | sterility, device malfunction |
| UPC / GTIN / UDI-DI | 00850027193205 |
| Lot numbers | 85438, 86445 |
| Model numbers | 60566REVB |
| Expiration dates | 2023-10-28 |
Product
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1970-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.