Lower riskMedical device recall · FDA · Published November 4, 2021
ROi CPS Newborn Kit Recall: Non-sterile needles pose health risk
ROi CPS recalls newborn kits with non-sterile needles. This may cause infections if used for medical procedures. Affected kits have specific item numbers and expiration dates.
“ROi CPS Newborn Kit Recall: Non-sterile needles pose health risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61586-roi-cps-newborn-kit-recall-non-sterile-needles-pose-health. Based on FDA recall #Z-0411-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0411-2022%22&limit=1).
ROi CPS LLC voluntarily recalled a newborn kit containing non-sterile needles, the FDA said on Nov. 4, 2021. The Food and Drug Administration announced the Class II recall of Item Number 830096005.
How to tell if you have it
Brand: ROi CPS
Product: regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles
UPC: 10194717112938
Lot #90074
Expiration date: 04/17/2023
Distribution: Missouri
The hazard
The kit contains a non-sterile needle. The FDA classified the recall as Class II.
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since Jan. 3, 2020. Other recent recalls include a Dec. 26, 2024 recall for risk of ineffective ventilation and a July 24, 2024 recall for medical convenience kits with Merit syringes. Similar recent recalls of similar products include Medline Convenience Kits recalls announced on Jan. 7, 2026 regarding contaminated sterile products and calibration issues.
How to tell if you have this one
Check for item number 830096005, OB01054E on the kit. The kit may have lot number 90074 with an expiration date of April 17, 2023.
Brand
ROi CPS
Product
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for item number 830096005, OB01054E and lot number 90074 on the kit.
Where it went and when
Where it was distributed
Distributed in Missouri.
Listed by the agency
Not listed
FDA distribution: “Distribution was made to Missouri. There was no foreign/military/government distribution.” 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-0411-2022 (November 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0411-2022 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.