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RecallWatchMedical Device Safety
Class IIOngoingZ-0490-2026

Stryker Sustainability Solutions recalls HARMONIC FOCUS Shears + Adaptive Tissue Technology

Stryker Sustainability SolutionsTempe, AZ, United StatesReported Nov 19, 2025 · 9 months ago
Legal News Analyst ·

Reason for recall

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RXONLY
    204 affected lots
    1627516416284043162880551629432716296918163xxxxx1630149616305751
    +196 more163063471630643616316531163166511634238916343642163463251634661216347602163486781634918716353884163555451635718916360679163637881636639616367903163682451637595116376461163785001638007916382574163839571638640216399914164xxxxx1640530816407386164087321641069016413617164139751641626116418939164205201642283016432199164323421643687116436987164427251644447716446841164488571644920816449296164531401645924816463302164648951646719916471023164757461648255816487182164882521649120616492941164949261649795016498718165xxxxx16502233165038561650626916507481165118661651199516514496165145791652005316521262165218921652260316527022165278581653060216531805165345811653559516538257165392321654032216540636165495921655165816554621165596251656706816567902165696801657387216575403165763661657641816579676165830681658537816587095165872921659200916592273165950991659561116598700166xxxxx166025781660425816607822166122461661433016617406166257031663007916630328166323531663652816640175166411671664429916645144166457681664978616652064166551931665653616659901166614151666417616681913166832661669015116693679167xxxxx167057481675949116762280167639271676628216767078167681381676872416769146167759821677874516779900167957171679657816797254167973811679738116799710168xxxxx16801351168015641680449816806005168210361682817716843649168441031684849316852781168646071686726816881353168886501689532116898535169xxxxx169101071691345416920690169286821693118016935100169456441695137216962742169674191696939516977884169792761698136516988861169916981699358116996795170xxxxx1700182517009610170128251701620417021294

What the firm is doing

On September 23, 2025, Stryker issued an "Urgent: Medical Device Recall" notification dated September 22, 2025, to affected consignees. Styker asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete and return the Business Reply Form to SSSPFA@Stryker.com or use the QR Code on Attachment A. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. For any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422.

DistributionShow details

US Nationwide distribution and OUS (foreign) to country of: Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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