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Ra Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Ra Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Ra Medical Systems, Inc.

Date Product Reason Class
Oct 16, 2020 DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a cha... Due to footswitch not meeting required specification for protection from ingr... Class II
Jul 24, 2020 DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intend... Due to the taller wheel mounting on the laser, the laser may fall over potent... Class II
Jan 23, 2020 DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an ... A software issue was identified which could result in user or patient injury,... Class II
Sep 19, 2019 Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-0904... The firm has become aware there is a potential problem with its DABRA cathete... Class II
Aug 23, 2019 Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime... At doses of less than 100 mJ, in custom and auto repeat modes, a software err... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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