Micro Therapeutics recalls 2 units of Pipeline Flex Embolization Device with Shield Technology (UDI-DI: 00763000448806) due to incorrect diameter labeling. Product is labeled 2.50mm but should be 3.00mm.
“Micro Therapeutics Pipeline Flex Embolization Device Recall: Incorrect Diameter Label.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449693-micro-therapeutics-inc-recalls-pipeline-flex-embolization-device-with-shield. Based on FDA recall #Z-3326-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3326-2026%22&limit=1).
The FDA announced on June 25, 2026, that Micro Therapeutics, Inc. is recalling the Pipeline Flex Embolization Device with Shield Technology due to incorrect label and product dimensions. The hazard involves units being packaged as a different diameter than labeled.
How to tell if you have it
Brand: Micro Therapeutics
Product: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12
UDI-DI code: 00763000448806
Lot Number: #D112860
UPC: 00763000448806
The hazard
The product is supposed to be 3.00 mm in diameter, but the unit in packaging was a 2.50 mm in diameter. This discrepancy constitutes the hazard for this Class II recall.
Context
GovInfoNow's records show Micro Therapeutics, Inc. has 6 other recalls on record since July 13, 2021. A similar labeling error occurred on June 8, 2026, involving Pipeline Flex Embolization Device implants containing incorrect lengths. Other recent recalls of similar products include DeRoyal Myocardial Probe Recall (Aug. 20, 2026), Centinel Prodisc C SK U.S. Implant Extra Large 5mm - Labeling Mixup Recall (March 20, 2026), and EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026).
How to tell if you have this one
Check for the UDI-DI code 00763000448806 on the packaging. The product is labeled as 2.50mm but should be 3.00mm. Only two units were distributed in Georgia and Texas.
Brand
Micro Therapeutics
Product
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for the UDI-DI code 00763000448806 on the packaging to confirm if the device is part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of GA and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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-3326-2026 (June 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3326-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 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.