ModerateClass IITerminated

FDA Devices recall · Reported August 14, 2019

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 with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2218-2019.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Lasers/Catheters did not calibrate during set-up prior to use.

Recall #: Z-2218-2019
Affected scope: 4
Initiated: February 15, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Ra Medical Systems Inc recalled The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascul… - a moderate-severity action.

The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascul… was recalled by Ra Medical Systems Inc in August 14, 2019. Reason: Lasers/Catheters did not calibrate during set-up prior to use.. Check the official notice for the remedy. Verify recall #Z-2218-2019 with the FDA Devices before acting.

The recall

Ra Medical Systems Inc issued this moderate-severity FDA Devices recall-Lasers/Catheters did not calibrate during set-up prior to use..

Moderate
severity level: 4 units
affected scope: Class II
classification: August 14, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2218-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.

Reason for recall

Lasers/Catheters did not calibrate during set-up prior to use.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2218-2019
Date reported	August 14, 2019
Date initiated	February 15, 2018
Recalling firm	Ra Medical Systems Inc
Firm location	Carlsbad, CA
Affected scope	4
Distribution	U.S: CA, PA

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

4 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2218-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Lasers/Catheters did not calibrate during set-up prior to use.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2218-2019.

Where was the recalled product distributed? ▼

Distribution: U.S: CA, PA.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported August 14, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026