CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Cardiohelp System HKH 8820 Wall Holder recalled
Maquet Cardiopulmonary is recalling Cardiohelp System HKH 8820 Wall Holder, distributed in Illinois, Missouri. The recall was initiated on 30 Apr 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-1823-2025
- FDA event ID
- 96820
- Recalling firm
- Maquet Cardiopulmonary, Rastatt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2025
- FDA classified
- 27 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2025 | Recall initiated by company | |
| 27 May 2025 | Classified by FDA | +27 days |
| 4 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Which lots are affected?
Model No. 701045366; UDI 04037691456584; All Serial No.
Where was it sold?
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 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.
More recalls from Maquet Cardiopulmonary
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Sprinter Cart/Sprinter Cart XL Infusion Pole recalled | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |