Sharp Medical Products SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Brand
Sharp Medical Products
Lot Codes / Batch Numbers
Catalogue Number: 100-36-01 Lot Number: 0818-009
Products Sold
Catalogue Number: 100-36-01 Lot Number: 0818-009
Sharp Medical Products is recalling SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult due to Non-conformity (holes/punctures or deep creases) in the sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Recommended Action
Per FDA guidance
On 02/08/2021 the firm began notifying customers and received confirmation that affected lot was still on customers shelves. On 03/03/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via certified US mail informing customers that they have become aware of product that either have holes or deep creases in the sterile barrier that makes the product unsafe for use and could lead to patient infection, sepsis, or death if used. Customer are instructed: 1.That any/all remaining units on their shelves should be disposed of in the trash. 2. Complete "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and scan and send via email to Carolyn.urish@sharpmedicalproducts.com or send via mail to attention of Carolyn Urish at 14362 N Frank Lloyd Wright, Scottdales AZ, 85260. Any questions or further guidance - contact the Recalling Firm at email carolyn.urish@sharpmedicalproducts.com or by phone at 630-232-8002 ext. 5 Monday through Friday 8:00 a.m. to 4:30 p.m. Mountain Time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, MI, OH, TX, WI
Page updated: Jan 10, 2026