Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1970-2023 — SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

U.S. FDA — Device Enforcement · United States · 2023-04-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1970-2023
Date of alert
2023-04-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LumiraDx
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850027193205
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.