Microvention recalls HydroPearl Compressible Microspheres (REF 8HP2S600) due to manufacturing defects that may affect safety. Learn if your product is affected and what to do.
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
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Contact the company
📍Recalling firmMICROVENTION INC.35 Enterprise · Aliso Viejo, CA 92656
“Microvention HydroPearl Compressible Microspheres Recall: Manufacturing Defect Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56508-microvention-hydropearl-compressible-microspheres-recall-manufacturing-defect-risk. Based on FDA recall #Z-0868-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0868-2024%22&limit=1).
The FDA announced on Dec. 21, 2023, that Microvention Inc. is recalling TERUMO HydroPearl Compressible Microspheres for Embolisation because manufacturing processes were not followed. The agency classified the recall as Class II.
How to tell if you have it
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Model/Catalog Number: HP2S0600
Lot Number: 0000342047
UPC: 00816777026118
The hazard
The FDA stated that the prescribed manufacturing and quality processes were not followed during production, leading to inadvertent distribution of the product.
Context
GovInfoNow's records show Microvention Inc. has 15 other recalls on record since Aug. 7, 2017. Recent Microvention recalls include a Bobby Balloon Guide Catheter recall on April 30, 2026, for balloon pinhole defects and an LVIS Stent Device recall on April 6, 2026, regarding vessel injury risks. Other recent recalls of similar products include an Embosphere 500-700 Micrometer Syringe recall on Aug. 10, 2026, for packaging holes risk infection and a Micro Therapeutics Pipeline Flex Embolization Device recall on June 25, 2026, for incorrect diameter labeling.
How to tell if you have this one
Check for the model number HP2S0600 and the lot number 0000342047 on the product label. The UDI code (01)00816777026118(11)230710(17)260630(10)0000342047 is also associated with this recall.
Brand
Microvention
Product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model number HP2S0600 and lot number 0000342047 on the device label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Illinois, Louisiana, North Carolina, Tennessee, Virginia, Wisconsin.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0868-2024 (December 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0868-2024 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.