FDA Device recall Z-1970-2023
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area by Lumiradx, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1970-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-25 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lumiradx |
| Distribution | US |
Product
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Reason
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
Identifiers
| code_info | GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.