Stryker Neurovascular 9F Balloon Guide Catheter Recall: Labeling Error Risk
Stryker Neurovascular recalls 9F Balloon Guide Catheters due to labeling error where 8F catheters were packaged with 9F. This affects specific lot numbers sold outside the US. No action needed as the product was not distributed in the US.
Lower-risk recall
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Contact the company
What happened, in plain English
Stryker Neurovascular is recalling 9F Balloon Guide Catheters because 8F catheters were mistakenly packaged with them. This labeling error does not pose a safety risk since the affected lot was not distributed in the US and no action is required. Read more at govinfonow.com/recall/69481-stryker-neurovascular-9f-balloon-guide-catheter-recall-labeling-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69481-stryker-neurovascular-9f-balloon-guide-catheter-recall-labeling-error-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0065-2020
Cite this page
“Stryker Neurovascular 9F Balloon Guide Catheter Recall: Labeling Error Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69481-stryker-neurovascular-9f-balloon-guide-catheter-recall-labeling-error-risk. Based on FDA recall #Z-0065-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0065-2020%22&limit=1).
Why it’s dangerous
The hazard involves a labeling error where 8F Balloon Guide Catheters were packaged within the 9F packaging. However, this error does not create a safety risk because the affected lot was not distributed in the US.
Who’s affected
The recall applies to specific lot numbers of 9F Balloon Guide Catheters that were not distributed in the US. No consumers in the US are affected by this recall.
How to tell if you have this one
Check for the lot number 0000010779 on the packaging. The product was not distributed in the US, so no US consumers are affected by this recall.
- Brand
Stryker Neurovascular- Product
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for lot number 0000010779 on the packaging. This lot was not distributed in the US, so no action is needed.
How this recall unfolded
Recall timeline
FDA terminated this recall 21 months 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-0065-2020 (November 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0065-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.