FDA Medical devices recall ·
Cardiohelp System HKH 8820 Wall Holder recall
- Recall number
- Z-1823-2025
- Date
- (initiated April 30, 2025)
- Company / brand
- Maquet Cardiopulmonary Ag
Kehler Str. 31, Rastatt, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- US: 2 units; OUS: 168 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Why was it recalled?
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
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
Model No. 701045366; UDI 04037691456584; All Serial No.
Distribution
Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand.
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-1823-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.