ReCor Medical Inc. recalls Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product…
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Read the official notice →- Date
- 2026-04-08
- Country
- United States
- Brand
- ReCor Medical Inc.
- Product
- Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2026-04-08
USBD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA; Catalog No.: 446948.
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the…
FDA · DeviceBD KIESTRA LAB AUTOMATIONDomestic: KS, MD, MN, NJ, TX, VA; International: Australia, Austria, Belgium,…Official notice →- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Domestic: Nationwide Distribution International: Argentina, Australia,…Official notice → - US
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to…
- US
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
FDA · DevicePhilips Respironics, Inc.Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia…Official notice → - US
Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy…
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or…
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA;…
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
FDA · DeviceAbiomed, Inc.International distribution in the country of Australia, Canada, France,…Official notice →