Invuity PhotonBlade REF PB1 Recall: Possible Tissue Damage Risk
Invuity recalls PhotonBlade REF PB1 devices due to possible unintended energy discharge causing tissue damage. All units are affected.
Lower-risk recall
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
Contact the company
What happened, in plain English
Invuity is recalling all PhotonBlade REF PB1 devices after reports of possible unintended energy discharge that could cause tissue damage. This risk affects patients during use of the device. Read more at govinfonow.com/recall/73882-invuity-photonblade-ref-pb1-recall-possible-tissue-damage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73882-invuity-photonblade-ref-pb1-recall-possible-tissue-damage-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2778-2017
Cite this page
“Invuity PhotonBlade REF PB1 Recall: Possible Tissue Damage Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73882-invuity-photonblade-ref-pb1-recall-possible-tissue-damage-risk. Based on FDA recall #Z-2778-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2778-2017%22&limit=1).
Why it’s dangerous
The device may discharge energy unexpectedly during use, potentially damaging patient tissue. This issue is reported in a small number of customer observations.
Who’s affected
Patients using the Invuity PhotonBlade REF PB: All units are affected. The risk is low as it involves only a small number of customer observations.
How to tell if you have this one
Check for the Invuity PhotonBlade REF PB1 model. All lot numbers are affected, so no specific model or lot number is safe.
- Brand
Invuity- Category
Medical device
What to do — step by step
Check Device Model
Look for the Invuity PhotonBlade REF PB1 model on the device.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2778-2017 (June 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2778-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.