UnratedMedical device recall · FDA · Published January 19, 2021
Stryker Harmonic ACE +7 Shears Recall: Unapproved Medical Device
Stryker recalls Harmonic ACE +7 Shears with Advanced Hemostasis due to distribution without regulatory clearance. Affected units include specific model and lot numbers. Consumers should contact Stryker for details.
“Stryker Harmonic ACE +7 Shears Recall: Unapproved Medical Device.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63363-stryker-harmonic-ace-7-shears-recall-unapproved-medical-device. Based on FDA recall #Z-1327-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2021%22&limit=1).
The FDA announced on Jan. 19, 2021, that Stryker Sustainability Solutions is recalling Stryker Sustainability Solutions REF HARH36 Harmonic ACE +7 Shears because they were distributed without regulatory clearance. The recall affects 102 units distributed worldwide and in Ohio and Israel.
How to tell if you have it
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis
UPC: 07613327346251
Lot Number: 12444050
The hazard
The product was distributed without receiving regulatory clearance, according to the FDA. The instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Context
GovInfoNow's records show Stryker Sustainability Solutions has 22 other recalls on record since Dec. 1, 2017. Other recent recalls include the Stryker XCEL Bladeless Trocar W/Optiview (Aug. 19, 2026), Bard EP XT Decapolar Catheter (Aug. 18, 2026), and Stryker Daig Livewire Steerable BDB Catheter (April 10, 2026). Other recent recalls of similar products include Healthmark Mesh Tip Protectors (March 12, 2026) and Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK (Feb. 25, 2026).
How to tell if you have this one
Check for the model number HARH36 and lot number 12444050 on the product. The product was sold with a specific catalog number and GTIN.
Brand
Stryker
Product
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Stryker
Reach out to Stryker Sustainability Solutions for specific instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1327-2021 (January 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1327-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.