Lower riskMedical device recall · FDA · Published May 23, 2025
Integra MicroMyst Applicator Recall: Lack of Sterility Risk
Integra LifeSciences recalls MicroMyst Applicators due to lack of sterility assurance. Affected units include all lots of model 20500:500DS. Consumers should contact Integra for details.
“Integra MicroMyst Applicator Recall: Lack of Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52226-integra-micromyst-applicator-recall-lack-of-sterility-risk. Based on FDA recall #Z-1961-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1961-2025%22&limit=1).
Integra LifeSciences Corp. (NeuroSciences) recalled the MicroMyst Applicator, Box of 5, due to a lack of sterility assurance, according to the FDA on May 23, 2025.
How to tell if you have it
Brand: Integra
Product: MicroMyst Applicator, Box of 5
Model/Catalog Number: 205000DS
UDI No.: 10381780000112
Lots: All lots
The hazard
The recall addresses a lack of sterility assurance in the MicroMyst Applicator, which consists of a multilumen applicator and filtered line for use with the Integra Flow Source.
Context
GovInfoNow's records show Integra LifeSciences Corp. (NeuroSciences) has 12 other recalls on record since April 4, 2025. Other recent recalls of similar products include Codman CerebroFlo EVD Catheter Recall: Endotoxin Risk (April 10, 2026), Integra Cytal Burn Matrix 7x10 cm recall: Increased endotoxin risk (March 19, 2026), and Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (Jan. 7, 2026).
How to tell if you have this one
Check for the model number 205000DS on the applicator box. All lots of this product are affected.
Brand
Integra
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Integra
Reach out to Integra LifeSciences for specific instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-1961-2025 (May 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1961-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.