Z-2484-2018Class II

Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36

Name: Z-2484-2018 Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36
Creator: Stryker Sustainability Solutions
Published: 2018-05-08
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2018-05-08 / Terminated / root cause: design

FDA source

Stryker Sustainability Solutions began a recall of Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm... on 2018-05-08. FDA classified it as Class II and gives the reason as "Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2484-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-07-18
Terminated: 2019-07-29
Recalling firm: Stryker Sustainability Solutions
Product: Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.
Product code: NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reason for recall: Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.
Root cause tag: design
FDA root cause: Device Design
Action: Firm notified sales reps via email on 5/8/18 and instructed to have the customers complete response forms.
Quantity in commerce: 180 units
Distribution: US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN
Product codes and lots: Lot number 7656512

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2484-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2484-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18

Product code NLQ

K161693UnclassifiedReprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions / cleared 2017-02-23

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)