Drugs & medicalClass II

Maquet Cardiopulmonary Ag recalls Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by…

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

Read the official notice →
Date
2025-06-04
Country
United States
Brand
Maquet Cardiopulmonary
Product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Classification
Class II
Units
Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Maquet Cardiopulmonary recalls

  1. 2026-09-23
  2. US
    Drugs & medicalClass II

    Maquet Cardiopulmonary Gmbh recalls Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

    The packaging may not consistently maintain sterile barrier integrity.

    FDA · DeviceMaquet Cardiopulmonary GmbhWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  3. 2026-02-11
  4. US
    Drugs & medicalClass II

    Maquet Cardiopulmonary Gmbh recalls Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

    Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the…

    FDA · DeviceMaquet Cardiopulmonary GmbhWorldwide Distribution: US (Nationwide) and OUS (International) to countries…Official notice →
  5. 2025-08-06
  6. US
    Drugs & medicalClass II

    Maquet Cardiopulmonary Gmbh recalls Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    Device does not comply with the labeling requirements of international standard IEC 60601-1.

    FDA · DeviceMaquet Cardiopulmonary GmbhWorldwide distribution - US Nationwide and the countries of Australia, New…Official notice →
All 4 Maquet Cardiopulmonary recalls →

Other drugs & medical recalls in the United States

  1. 2025-06-04
  2. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

    FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.Official notice →
  3. US
    Drugs & medicalClass II

    Prismatik Dentalcraft, Inc. recalls Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The…

    Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

    FDA · DevicePrismatik Dentalcraft, Inc.U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.Official notice →
  4. US
    Drugs & medicalClass II

    Mckesson Medical-Surgical Inc. Corporate Office recalls SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

    transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an…

    FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR,…Official notice →
  5. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  6. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

    Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems…

    FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of California, Kentucky, and Wisconsin.Official notice →
  7. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436,…

    There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.

    FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of BAHRAIN, Canada,…Official notice →
See all drugs & medical recalls →