Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 25, 2018
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 struc
Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remainin…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Sustainability Solutions recalled Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item N… - a moderate-severity action.
Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item N… was recalled by Stryker Sustainability Solutions in July 25, 2018. Reason: Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed…. Check the official notice for the remedy. Verify recall #Z-2484-2018 with the FDA Devices before acting.
The recall
Stryker Sustainability Solutions issued this moderate-severity FDA Devices recall-Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed….
- Moderate
- severity level
- 180 units
- affected scope
- Class II
- classification
- July 25, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2484-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2484-2018) was formally reported on July 25, 2018, with the manufacturer initiating the action on May 8, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Sustainability Solutions is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 180 units.
The documented reason for this recall is: 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 genera… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
180 units
Related Recalls
6
0 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2484-2018 |
| Date reported | July 25, 2018 |
| Date initiated | May 8, 2018 |
| Recalling firm | Stryker Sustainability Solutions |
| Firm location | Tempe, AZ |
| Affected scope | 180 units |
| Distribution | US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2484-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Sustainability Solutions. Units affected: 180 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2484-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2484-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.