FDA Medical Device Recalls (openFDA)
Sharp Medical Products: SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
- Recall number
- Z-1366-2021
- Recalling firm
- Sharp Medical Products
- Product
- SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
- Status
- Terminated
- Initiated
- 2021-02-08
- Posted
- not on file
- Terminated
- 2023-02-17
- Reason
- Non-conformity (holes/punctures or deep creases) in the sterile barrier.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 129 units (63 units for Human-use and 66 units for Non-Human use)
- Distribution
- U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
- Lot, serial or model codes
- Catalogue Number: 100-36-01 Lot Number: 0818-009
- 510(k) numbers
- ["K150549"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3017828726
- Firm city
- Scottsdale
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28