Lower riskMedical device recall · FDA · Published November 5, 2021
DigniCap Delta Scalp Cooling System: Updated Headband Use Instructions
DigniCap Delta Scalp Cooling System (PN 900-1001) recalls updated user manual for headband use and condensation risks. Affected units: Serial numbers A65860-A73244.
Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.
“DigniCap Delta Scalp Cooling System: Updated Headband Use Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61563-dignicap-delta-scalp-cooling-system-updated-headband-use-instructions. Based on FDA recall #Z-0825-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2022%22&limit=1).
The FDA announced on Nov. 5, 2021, that Dignitana, Inc. is recalling the DigniCap Delta Scalp Cooling System due to labeling issues. The company is updating instructions for use to include headband application and condensation warnings. Owners should contact Dignitana for updated documentation.
Distribution: Sold in LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY
The hazard
The recall addresses labeling deficiencies in the Instructions for Use. The updated instructions now recommend using a headband for all patients and provide guidance on applying it. The labeling also includes new warnings about the risk of condensation build-up depending on environmental conditions.
How to tell if you have this one
Check the product label for serial numbers A65860 to A73244. The DigniCap Delta Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C) is part of the recalled items.
Brand
Dignitana
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Updated Instructions
Check the user manual for the latest headband application instructions and condensation warnings.
Where it went and when
Where it was distributed
Distributed in 12 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Florida, Georgia, Kansas, Kentucky, Louisiana, New Jersey, New York, North Carolina, South Carolina, Wisconsin.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0825-2022 (November 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0825-2022 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.