Reported Apr 14, 2021 · Terminated

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

Sharp Medical Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sharp Medical Products · 14362 N Frank Lloyd Wright Blvd · Scottsdale, AZ · 85260-8846

Is this the product you have?

  • SHARP MEDICAL PRODUCTS, LLC
  • Reactor and Sleeve REF 100-36-01 SizeAdult
Lot codes and dates
  • Catalogue Number100-36-01
  • Lot Number0818-009
Amount recalled
129 units (63 units for Human-use and 66 units for Non-Human use)

Where it was sold

Why it was recalled

Non-conformity (holes/punctures or deep creases) in the sterile barrier.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 17, 2023 · Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.