Abbott FIRMap Catheter 60mm Basket: Incorrect Product Labeling Recall
Abbott recalls FIRMap Catheter 60mm Basket models with incorrect labeling. This may cause confusion in medical use. Affected units have specific batch numbers and expiration dates.
Lower-risk recall
Incorrect product labeling.
Contact the company
What happened, in plain English
Abbott is recalling FIRMap Catheter 60mm Baskets due to incorrect product labeling. This could lead to confusion in medical use, potentially affecting patient safety. Read more at govinfonow.com/recall/60750-abbott-firmap-catheter-60mm-basket-incorrect-product-labeling-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/60750-abbott-firmap-catheter-60mm-basket-incorrect-product-labeling-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1213-2022
Cite this page
“Abbott FIRMap Catheter 60mm Basket: Incorrect Product Labeling Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60750-abbott-firmap-catheter-60mm-basket-incorrect-product-labeling-recall. Based on FDA recall #Z-1213-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1213-2022%22&limit=1).
Why it’s dangerous
Incorrect labeling could lead to confusion about the product's specifications. This might result in improper use or incorrect medical procedures if healthcare providers mistake it for another model.
Who’s affected
Healthcare professionals using the catheter for medical procedures are most at risk. Patients receiving the catheter may also be affected if labeling causes errors.
How to tell if you have this one
Check for model number AR064060 and batch numbers listed: 2158303 (exp. 30 Nov 2022), 2159876 (exp. 31 Jan 2023), 2156510 (exp. 30 Sep 2022), 2162996 (exp. 31 Mar 2023), 2159875 (exp. 30 Nov 2022), or 2159877 (exp. 30 Nov 2022).
- Brand
Abbott- Category
Medical device
What to do — step by step
Check Product Label
Look for model number AR064060 and batch numbers listed in the description.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
FDA distribution: “US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Missouri, Ohio, Washington.
Recall timeline
FDA terminated this recall 2.1 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-1213-2022 (April 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1213-2022 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.