Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 7, 2021
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: 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
Product was distributed without receiving regulatory clearance.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Sustainability Solutions recalled Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, S… - a moderate-severity action.
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, S… was recalled by Stryker Sustainability Solutions in April 7, 2021. Reason: Product was distributed without receiving regulatory clearance.. Check the official notice for the remedy. Verify recall #Z-1327-2021 with the FDA Devices before acting.
The recall
Stryker Sustainability Solutions issued this moderate-severity FDA Devices recall-Product was distributed without receiving regulatory clearance..
- Moderate
- severity level
- 102 units
- affected scope
- Class II
- classification
- April 7, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1327-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1327-2021) was formally reported on April 7, 2021, with the manufacturer initiating the action on January 19, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker Sustainability Solutions is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 102 units.
The documented reason for this recall is: Product was distributed without receiving regulatory clearance. Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.. 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, 3 from FDA Devices - 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 - 40,322 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
102 units
Related Recalls
6
3 from same agency
Product description
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: 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.
Reason for recall
Product was distributed without receiving regulatory clearance.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1327-2021 |
| Date reported | April 7, 2021 |
| Date initiated | January 19, 2021 |
| Recalling firm | Stryker Sustainability Solutions |
| Firm location | Tempe, AZ |
| Affected scope | 102 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel. |
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-1327-2021) 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? ▼
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: 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.. Recalled by Stryker Sustainability Solutions. Units affected: 102 units.
Why was this product recalled? ▼
Product was distributed without receiving regulatory clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Moderate. Recall number: Z-1327-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1327-2021) 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 April 7, 2021. 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.