Spectrum Medical Inc recalls Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass,…
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Read the official notice →- Date
- 2025-03-19
- Country
- United States
- Brand
- Spectrum Medical
- Product
- Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass,…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of Alabama, Arizona,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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 Spectrum Medical recalls
- 2026-10-07
USSPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W…
Due to blood-to-glycol leak in the heat exchanger.
FDA · DeviceSPECTRUM MEDICAL SRLUS Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC,…Official notice →- 2025-05-07
- US
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product…
Medical device software marketed without FDA clearance .
FDA · DeviceSpectrum Medical Ltd.California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona,…Official notice → - 2024-10-30
- US
Spectrum Medical Ltd. recalls Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing.…
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
FDA · DeviceSpectrum Medical Ltd.US Nationwide distribution including in the states of Alabama, California,…Official notice →
Other drugs & medical recalls in the United States
- 2025-03-19
- US
Cordis US Corp recalls Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular…
Catheter manufactured at the incorrect length.
- US
Zimmer, Inc. recalls Z1 Femoral Hip System, Product Number 611777612
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
- US
Stryker Corporation recalls Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer…
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer…
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries of Alaska, Arizona,…Official notice → - US
Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.