Use cautionMedical device recall · FDA · Published June 14, 2021
Regard Newborn Kit Heel Warmer: Use Away From Face and Infant to Prevent Burns
Regard NEWBORN KIT (LD00201K) with infant heel warmer may cause burns if used too close to face or infant. Recalled lot numbers: 77906K, 78673K, 79327K, 80825K.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Take action
Contact the company
📍Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
“Regard Newborn Kit Heel Warmer: Use Away From Face and Infant to Prevent Burns.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62336-regard-newborn-kit-heel-warmer-use-away-from-face-and. Based on FDA recall #Z-2168-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2168-2021%22&limit=1).
ROi CPS LLC recalled the Regard NEWBORN KIT, LD00201K, Item Number 830016011, on June 14, 2021, according to the FDA. The recall updates instructions for the included infant heel warmer to include a cautionary statement about activation distance.
How to tell if you have it
Brand: Regard
Product: NEWBORN KIT
Model/Lot: LD00201K
Item Number: 830016011
Lot Numbers: 77906K, 78673K, 79327K, 80825K
Quantity: 688 units
Distribution: Missouri
The hazard
The recall updates the instructions for use to include a cautionary statement for the heel warmer: "Activate away from the user's face and away from the infant and others."
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since Jan. 3, 2020. Other recent recalls of similar products include a Dec. 26, 2024 recall for risk of ineffective ventilation and a July 24, 2024 recall for medical convenience kits with Merit syringes.
How to tell if you have this one
Check for the Regard NEWBORN KIT with model LD00201K and item number 830016011. The recalled lot numbers are 77906K, 78673K, 79327K, and 80825K.
Brand
Regard
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Missouri
Recall number
Product, codes & lots
Quantity
Z-2167-2021
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.; Lot Numbers: 71562J, 73679J, 74808J, 75222J
608 units
Z-2168-2021
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.; Lot Numbers: 77906K, 78673K, 79327K, 80825K
688 units
Z-2169-2021
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.; Lot Numbers: 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, 88687M
976 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model number LD00201K and item number 830016011 on the kit.
Use Away From Face
Activate the warmer at least 12 inches away from the baby's face and body to prevent burns.
Where it went and when
Where it was distributed
Distributed in Missouri.
Listed by the agency
Not listed
FDA distribution: “Missouri” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA terminated this recall 21 months 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-2168-2021 (June 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2168-2021 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.