Ra Medical Systems, Inc.

FDA recalling firm · 7 enforcement events · 7 product records · 2014–2020 · CA

Ra Medical Systems, Inc. has 7 FDA enforcement events on this register (7 product records) between 2014 and 2020: 7 device; the busiest year was 2020 with 3.

0% of its events are Class I; the most common class is Class II (7). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
16 Oct 2020	DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.	Device	Class II	1	Terminated
24 Jul 2020	DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.	Device	Class II	1	Terminated
23 Jan 2020	DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with…	Device	Class II	1	Terminated
19 Sep 2019	Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY:…	Device	Class II	1	Terminated
23 Aug 2019	Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the…	Device	Class II	1	Terminated
15 Feb 2018	The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor…	Device	Class II	1	Terminated
30 Jun 2014	PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma	Device	Class II	1	Terminated

By type and class

Device7

Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Ra Medical Systems, Inc. by year initiated.

Questions and answers

How many FDA recalls has Ra Medical Systems, Inc. had?

7 enforcement events (7 product records) on this register, 2014–2020: 7 device.

Are any Ra Medical Systems, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Ra Medical Systems, Inc. recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.