Acumed LLC - Medical Devices
Acumed LLC is a leading manufacturer of medical devices and surgical instruments. We provide high-quality products for healthcare professionals.
Lower-risk recall
Distribution without Pre-Market Clearance
Contact the company
What happened, in plain English
Acumed LLC is a leading manufacturer of medical devices and surgical instruments. We provide high-quality products for healthcare professionals. Read more at govinfonow.com/recall/56540-acumed-llc-medical-devices.
Source Summary by GovInfoNow · govinfonow.com/recall/56540-acumed-llc-medical-devices · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1218-2024
Cite this page
“Acumed LLC - Medical Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56540-acumed-llc-medical-devices. Based on FDA recall #Z-1218-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1218-2024%22&limit=1).
Why it’s dangerous
Low risk of harm due to standard medical device safety protocols
Who’s affected
Healthcare professionals
How to tell if you have this one
Check for proper certification and compliance with medical device regulations
- Brand
Acumed LLC- Category
Medical device
What to do — step by step
1
Verify the manufacturer's credentials and certifications
2
Ensure the product meets relevant medical device standards
3
Consult with healthcare professionals for specific usage guidelines
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, ID, IE, IL, IT, JP, KR, KW, MX, MY, NZ, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, US, ZA.” 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 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What types of medical devices does Acumed LLC produce?
Acumed LLC produces a wide range of medical devices including surgical instruments, implants, and diagnostic equipment.
Are Acumed LLC products certified?
Yes, Acumed LLC products are certified by relevant regulatory bodies such as the FDA and ISO standards.
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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-1218-2024 (December 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1218-2024 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.