ConMed STAT 2.5 I.V. Gravity Flow Controllers Recalled for Inaccurate Fluid Flow Rates
ConMed recalls STAT 2.5 I.V. gravity flow controllers and administration sets due to inconsistent fluid flow rates. Affected units include specific catalog numbers and production dates from April 2012 to February 2017.
Lower-risk recall
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Contact the company
What happened, in plain English
ConMed is recalling STAT 2.5 I.V. gravity flow controllers and administration sets because they may deliver inaccurate or inconsistent fluid flow rates during intravenous treatments. This could lead to improper medication dosing or treatment complications if the flow rate is not properly controlled. Read more at govinfonow.com/recall/73825-conmed-stat-2-5-i-v-gravity-flow-controllers-recalled.
Source Summary by GovInfoNow · govinfonow.com/recall/73825-conmed-stat-2-5-i-v-gravity-flow-controllers-recalled · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0804-2018
Cite this page
“ConMed STAT 2.5 I.V. Gravity Flow Controllers Recalled for Inaccurate Fluid Flow Rates.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73825-conmed-stat-2-5-i-v-gravity-flow-controllers-recalled. Based on FDA recall #Z-0804-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2018%22&limit=1).
Why it’s dangerous
The recalled devices may not deliver fluids at the intended rate, which could result in under- or over-administration of medications or fluids. This inconsistency might cause treatment complications if the flow rate is not properly controlled during medical procedures.
Who’s affected
Healthcare professionals and patients using the recalled STAT 2.5 I.V. gravity flow controllers and administration sets for intravenous fluid administration. Those most at risk are individuals receiving IV treatments with the affected products.
How to tell if you have this one
Check for catalog numbers S2, S2-12, S2-20 MD, S2V-20, or S2V-60 on the product packaging. The products were manufactured between April 27, 2012, and February 1, 2017, with specific lot codes.
- Brand
ConMed- Category
Medical device
All 2 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
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0804-2018 | STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.; Catalog Number, Manufacturing Date range, Lot Code range: (1) S2, 4/27/12 - 2/1/17, 120427X - 201702014; (2) S2-12, 4/27/12 - 3/13/17, 120427X - 201703134; (3) S2-20 MD, 4/27/12 - 1/2/17, 120427X - 201701024; (4) S2V-20, 4/27/12 - 4/7/17, 120427X - 201704074; and (5) S2V-60, 4/27/12 - 3/16/17, 120427X - 201703164 | 1,612,440 in total |
| Z-0805-2018 | STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.; Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124; (2) S2V-20 N, 4/27/12 - 11/7/17, 120427X - 201611074; and (3) S2V-60 N, 4/27/12 - 2/13/17, 120427X - 201702134 | 1,612,440in total |
What to do — step by step
Check Product Details
Identify the catalog number and production dates to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 5.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0804-2018 (June 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0804-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.