Z-1366-2021Class II

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

Name: Z-1366-2021 SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Creator: Sharp Medical Products
Published: 2021-02-08
License: https://open.fda.gov/license/

SharpMed, LLC / initiated 2021-02-08 / Terminated / root cause: packaging

FDA source

Sharp Medical Products began a recall of SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult on 2021-02-08. FDA classified it as Class II and gives the reason as "Non-conformity (holes/punctures or deep creases) in the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1366-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-08
Posted: 2021-04-06
Terminated: 2023-02-17
Recalling firm: SharpMed, LLC
Product: SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Root cause tag: packaging
FDA 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 [email protected] 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 [email protected] or by phone at 630-232-8002 ext. 5 Monday through Friday 8:00 a.m. to 4:30 p.m. Mountain Time.
Quantity in commerce: 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
Product codes and lots: Catalogue Number: 100-36-01 Lot Number: 0818-009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1366-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1366-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-06

Product code GCJ

K150549Class IIReactor(TM) Trocar and SleeveSharp Medical Prducts, LLC / cleared 2015-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)