CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2337-2025
- FDA event ID
- 97315
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2025
- FDA classified
- 18 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 30 Jul 2025 | Recall initiated by company | |
| 18 Aug 2025 | Classified by FDA | +19 days |
| 27 Aug 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Product as listed by the FDA
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Where it was distributed
US Nationwide distribution in the state of Georgia.
Questions about this recall
Why was it recalled?
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Which lots are affected?
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Where was it sold?
US Nationwide distribution in the state of Georgia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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