FDA Medical devices recall ·
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031… recall
- Recall number
- Z-2672-2025
- Date
- (initiated August 8, 2025)
- Company / brand
- Schiller, Ag
Altgasse 68, Baar, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 266 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Why was it recalled?
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: 1A.701307: UDI- 07613365003024 REF: 3.921002, UDI: 07613365001914 REF: 3.921030, UDI: 07613365003468 REF: 3.921031: UDI: 07613365003475 REF: 3.921006, UDI: 07613365000115 Affected Serial Numbers: 7010.000160 and lower, 7012.000356 and lower, 7013.000256 and lower, 7014.000152 and lower
Distribution
US Nationwide distribution in the states of MT, WI, IL.
States: Illinois Montana Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2672-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.