“Regard Obstetric Gynecologic Instruments Recall: Incorrect Expiration Date.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64100-regard-obstetric-gynecologic-instruments-recall-incorrect-expiration-date. Based on FDA recall #Z-0524-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0524-2021%22&limit=1).
ROi CPS LLC voluntarily recalled Regard labor and delivery kits on Oct. 12, 2020, due to labeling errors including incorrect expiration dates, the FDA said. The recall affects 220 units distributed in Missouri and Oklahoma.
Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C
Quantity: 220 kits
The hazard
The hazard involves a labeling error with an incorrect expiration date. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show ROi CPS LLC has issued 27 other recalls since Jan. 3, 2020. Recent brand recalls include a Dec. 26, 2024, Newborn Kit Recall for ventilation risks and a July 24, 2024, recall of Medical Convenience Kits with Merit Syringes. Other recent recalls of similar products include Inspire Stimulation Lead Recall (May 11, 2026) and Medline GYN/Laparoscopy CDS Products Recall (Jan. 7, 2026).
How to tell if you have this one
Check the lot numbers: 78483C, 79932C, 81043C, 82586C, or 83090C on Regard obstetric gynecologic instruments used in labor and delivery kits.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Verify the lot numbers on the instruments: 78483C, 79932C, 81043C, 82586C, or 83090C.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of MO and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Missouri, Oklahoma.
Recall timeline
FDA terminated this recall 7 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-0524-2021 (October 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0524-2021 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.