Ra Medical Systems DABRA Catheter 5F Recall: Shelf Life Calibration Failure Risk
Ra Medical Systems recalls DABRA Catheter 5F (1.5mm) models with potential calibration failures due to shelf life exceeding labeled expiration. Affected units have specific lot numbers and use-by dates.
Lower-risk recall
The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.
Contact the company
What happened, in plain English
Ra Medical Systems is recalling DABRA Catheter 5F (1.5mm) models that may have calibration failures because the product's actual shelf life is shorter than the labeled expiration date. This could lead to improper medical device calibration if used after the expiration date. Read more at govinfonow.com/recall/66979-ra-medical-systems-dabra-catheter-5f-recall-shelf-life-calibration.
Source Summary by GovInfoNow · govinfonow.com/recall/66979-ra-medical-systems-dabra-catheter-5f-recall-shelf-life-calibration · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2006-2020
Cite this page
“Ra Medical Systems DABRA Catheter 5F Recall: Shelf Life Calibration Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66979-ra-medical-systems-dabra-catheter-5f-recall-shelf-life-calibration. Based on FDA recall #Z-2006-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2020%22&limit=1).
Why it’s dangerous
The catheter's calibration may fail if used after the expiration date because the product's actual shelf life is shorter than the labeled expiration. This could lead to improper medical device calibration during procedures.
Who’s affected
Healthcare professionals using the DABRA Catheter 5F (1.5mm) for medical procedures are most at risk if they use units beyond the labeled expiration date. Patients receiving these catheters may face calibration issues if the device fails.
How to tell if you have this one
Check for the model DABRA Catheter 5F (1.5mm) with reference number 1222-5000-01. Look for lot numbers starting with 18-090400-094 or 19-092400-041 and use-by dates up to September 2019.
- Brand
Ra Medical Systems- Product
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE- Category
Medical device
What to do — step by step
Check Product Label
Look for the reference number 1222-5000-01 and lot numbers starting with 18-090400-094 or 19-092400-041 on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 31 states.
FDA distribution: “Worldwide Distribution - US Nationwide - MI, TN, CA, FL, OR, PA, AZ, AL, VA, GA, TX, ID, AR, NC, IN, SC, CT, NY, KS, LA, NV, MS, NE, MD, IL, OK, MA, WA, MO, WI, KY. OUS - Netherlands, Pakistan, United Kingdom, Italy, France” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2006-2020 (September 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2006-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.