The Recall Desk
HighFDA (Devices)·Z-1366-2021·Announced 2021-04-14

Sharp Medical Reactor and Sleeve Recalled for Sterile Barrier Defects

Sharp Medical Products is recalling 129 units of Reactor and Sleeve REF 100-36-01 due to holes, punctures, or deep creases in the sterile barrier.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a sterile barrier defect which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Sharp Medical Products, LLC is recalling 129 units of Reactor and Sleeve REF 100-36-01, Size: Adult. The recall involves 63 units intended for human use and 66 units for non-human use. The specific lot number is 0818-009 and the catalogue number is 100-36-01.

The recall was initiated because of non-conformities in the sterile barrier, specifically holes, punctures, or deep creases. These defects compromise the sterility of the medical device. The affected units were distributed in the United States to Arizona, Florida, Michigan, Ohio, Texas, and Wisconsin. No units were distributed outside the United States.

The U.S. Food and Drug Administration has classified this as a Class II recall. Users of these devices should stop using the affected units and contact Sharp Medical Products for further instructions.

The recalled product

Product
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Manufacturer
Sharp Medical Products
Category
Medical Device — Surgical Instruments
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalogue Number: 100-36-01 Lot Number: 0818-009

Distribution

Distributed in 6 states:

Related recalls

Same hazard · sterile barrier defect

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