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Unrated Medical device recall · FDA · Published July 24, 2024

ROi CPS Recalls Medical Convenience Kits with Merit Syringes - Safety Risk

ROi CPS recalls medical convenience kits containing Merit syringes (Jiangsu Shenli Medical Production) due to potential safety risks. Affected items have specific lot numbers and item numbers. Consumers should check their kits for these details.

🇺🇸 FDA recall #Z-3159-2024Medical deviceROi CPS ›
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Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
✎ GovInfoNow plain-language explainer

ROi CPS is recalling medical convenience kits that include Merit syringes from Jiangsu Shenli Medical Production. These kits may pose safety risks if used improperly, so affected consumers should stop using them and contact the company for details. Read more at govinfonow.com/recall/54566-roi-cps-recalls-medical-convenience-kits-with-merit-syringes-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/54566-roi-cps-recalls-medical-convenience-kits-with-merit-syringes-safety · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3159-2024

Cite this page

“ROi CPS Recalls Medical Convenience Kits with Merit Syringes - Safety Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54566-roi-cps-recalls-medical-convenience-kits-with-merit-syringes-safety. Based on FDA recall #Z-3159-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3159-2024%22&limit=1).

The FDA announced on July 24, 2024, that ROi CPS LLC is recalling Medical Convenience Kits distributed with Merit syringes. The hazard involves the inclusion of syringes that were subsequently recalled. Owners should contact the company for further instructions.

How to tell if you have it

  • Brand: ROi CPS
  • Product: regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE
  • Item Number: 800223009
  • UPC: 10194717114116
  • Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS
  • Distribution: US Nationwide distribution in the state of North Carolina

The hazard

Medical convenience kits were distributed with Merit syringes manufactured by Jiangsu Shenli Medical Production which were subsequently recalled.

Context

GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since 2020-01-03. Other recent recalls of similar products include ROi CPS Newborn Kit Recall (2024-12-26), ROi CPS Regard Kit Microtek Decanter Recall (2024-06-17), and ROi CPS Surgical Convenience Kit Recall (2023-12-18). Other recent recalls of similar products include Medline Convenience Kits with Unapproved Syringes Recalled (2026-02-27), Medline Convenience Kits Recall (2026-07-10), and Medline convenience kits recalled for potential contamination (2026-07-10).

How to tell if you have this one

Check your medical convenience kits for the item number 800223009 and lot numbers listed: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS.

  • Brand
    ROi CPS
  • Product
    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Identify your medical convenience kit by the item number 800223009 and lot numbers listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of North Carolina.” 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.

1. Firm started the recall: Jul 24, 202412. FDA classified it Class II: Sep 17, 202423. Published in FDA’s Enforcement Report: Sep 25, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-3159-2024 (July 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3159-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA