CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

Paradise ¿ Catheter recalled by ReCor Medical

ReCor Medical is recalling Paradise ¿ Catheter, distributed nationwide in the US. The recall was initiated on 29 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862

Quantity recalled24

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-1655-2026
FDA event ID: 98365
Recalling firm: ReCor Medical, Palo Alto, CA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jan 2026
FDA classified: 27 Mar 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

29 Jan 2026	Recall initiated by company
27 Mar 2026	Classified by FDA	+57 days
8 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Product as listed by the FDA

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

Where it was distributed

U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.

Nationwide California Colorado Florida Kansas Missouri North Carolina Ohio Texas Virginia

Questions about this recall

Why was it recalled?

Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Which lots are affected?

Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862

Where was it sold?

U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.

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.

Other products in this recall event

1 other product · FDA event 98365

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026	CLASS II	Paradise ¿ Catheter recalled by ReCor Medical	ReCor Medical	Other	Nationwide

More recalls from ReCor Medical

All 2

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Paradise ¿ Catheter recalled by ReCor Medical	ReCor Medical	Other	Nationwide

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