FDA Medical devices recall ·
Centerline Biomedical IOPS Guidewire 2 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1760-2025
- Date
- (initiated April 11, 2025)
- Company / brand
- Centerline Biomedical Inc
10000 Cedar Ave, Cleveland, OH, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 80 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Why was it recalled?
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
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
UDI/DI 00843152102037, Lot Number 2404-2005
Distribution
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
States: Florida North Carolina New Mexico New York Pennsylvania Tennessee Texas Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1760-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.