Lower riskMedical device recall · FDA · Published June 17, 2024
ROi CPS Regard Kit Microtek Decanter Recall: Pin Holes in Sterile Packaging
ROi CPS recalls Regard Kit with Microtek decanter due to pin holes and tears in sterile packaging that can't be seen. Affected units have specific lot numbers and expiration dates.
“ROi CPS Regard Kit Microtek Decanter Recall: Pin Holes in Sterile Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54821-roi-cps-regard-kit-microtek-decanter-recall-pin-holes-in. Based on FDA recall #Z-2685-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2024%22&limit=1).
ROi CPS LLC is voluntarily recalling Regard Kits containing the Microtek decanter due to potential pin holes and tears in sterile packaging that cannot be identified visually, the FDA said on June 17, 2024.
How to tell if you have it
Brand: ROi CPS
Product: Regard Kit containing the Microtek decanter
Item Number: 830099009
UDI: 10194717116677
Lot numbers: 99206 and 100633 (Expiration Date: 2024-09-15)
Distribution: US Nationwide distribution in the state of MO
The hazard
The decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since January 3, 2020. Recent brand recalls include a December 26, 2024 recall of Newborn Kits for risk of ineffective ventilation and a July 24, 2024 recall of Medical Convenience Kits with Merit Syringes due to safety risks. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), Stryker BARD Dynamic Deca Steerable Catheter Recall: Incomplete Seals Risk Infection (April 10, 2026), and Medline Convenience Kits Recall: Sterile Packaging Risk (June 12, 2026).
How to tell if you have this one
Check for Regard Kit containing Microtek decanter with lot numbers 99206 or 100633, both expiring September 15, 2024. The item number is 830099009.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging
Look for lot numbers 99206 or 100633 on the decanter packaging with expiration date September 15, 2024.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2685-2024 (June 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2685-2024 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.