Sharp Medical Products Reactor Sleeve Recall: Sterile Barrier Defect
Sharp Medical Products recalls Reactor and Sleeve REF 100-36-0: non-sterile barrier holes/punctures risk infection. Affected units have lot number 0818-009.
Lower-risk recall
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Contact the company
What happened, in plain English
Sharp Medical Products is recalling their Reactor and Sleeve REF 100-36-01 (adult size) due to holes or deep creases in the sterile barrier. This defect could allow contamination and infection during medical procedures. Read more at govinfonow.com/recall/63292-sharp-medical-products-reactor-sleeve-recall-sterile-barrier-defect.
Source Summary by GovInfoNow · govinfonow.com/recall/63292-sharp-medical-products-reactor-sleeve-recall-sterile-barrier-defect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1366-2021
Cite this page
“Sharp Medical Products Reactor Sleeve Recall: Sterile Barrier Defect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63292-sharp-medical-products-reactor-sleeve-recall-sterile-barrier-defect. Based on FDA recall #Z-1366-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1366-2021%22&limit=1).
Why it’s dangerous
The sterile barrier may develop holes or deep creases, compromising its ability to prevent contamination. This could lead to infections during medical procedures if the device is used without proper sterility.
Who’s affected
Healthcare professionals using the Reactor and Sleeve for medical procedures. Patients receiving procedures with this device are at risk of infection.
How to tell if you have this one
Check for the product name 'Reactor and Sleeve', model REF 100-36-01, adult size. Affected units have lot number 0818-009.
- Brand
Sharp Medical Products- Category
Medical device
What to do — step by step
Check Product Details
Identify the product name, model REF 100-36-01, adult size, and lot number 0818-009.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, Michigan, Ohio, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2 years 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-1366-2021 (February 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1366-2021 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.