# FDA recall Z-1970-2023

> **LumiraDx** · Class II · device recall initiated 2023-04-25.

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1970-2023
- **Recalling firm:** LumiraDx
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-25
- **Report date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1970-2023

## Citation

> AI Analytics. FDA recall Z-1970-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1970-2023. Source: US FDA. Licensed CC0.

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