Halyard Closed Suction System Recall: Risk of Saline Leaks Exposing to Infectious Agents
Halyard Health recalls adult suction systems with specific vial models due to potential saline leaks that could expose users to infectious agents. Affected units include specific product codes and lots.
Lower-risk recall
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
Contact the company
What happened, in plain English
Halyard Health is recalling adult suction systems that may leak saline, risking exposure to infectious agents. This affects specific product codes and lots sold in certain regions. Read more at govinfonow.com/recall/72884-halyard-closed-suction-system-recall-risk-of-saline-leaks-exposing.
Source Summary by GovInfoNow · govinfonow.com/recall/72884-halyard-closed-suction-system-recall-risk-of-saline-leaks-exposing · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0122-2018
Cite this page
“Halyard Closed Suction System Recall: Risk of Saline Leaks Exposing to Infectious Agents.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72884-halyard-closed-suction-system-recall-risk-of-saline-leaks-exposing. Based on FDA recall #Z-0122-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0122-2018%22&limit=1).
Why it’s dangerous
The saline vials in the system may leak, potentially exposing users to infectious agents. This risk is specific to the affected product codes and lots.
Who’s affected
Healthcare professionals using the Halyard Closed Suction System for adults are most at risk. Patients receiving care with these systems could be exposed if leaks occur.
How to tell if you have this one
Check for product codes 22012356 (Lot AB6032U10) or 2208A055 (Lot AB6291U17) on the suction system packaging.
- Brand
Halyard Health- Category
Medical device
All 9 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
Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
| Recall number | Product, codes & lots |
|---|---|
| Z-0117-2018 | Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.; Product Code 2216 with Lot AB6032U03; Product Code 22056 with Lot AB6032U12; Product Code 220569 with Lot AB6207U11 |
| Z-0118-2018 | Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.; Product Code 2276, Lots AB6018U03, AB6137U12, AB6305U17. |
| Z-0119-2018 | Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.; Product Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13 |
| Z-0120-2018 | Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.; Product Code 22169, Lots AB6123U08, AB6123U11 |
| Z-0121-2018 | Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.; Product Code 227056 with Lots AB6123U12, AB6284U18; Product Code 22701356 with Lot AB6207U12 |
| Z-0122-2018 | Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.; Product Code 22012356 with Lot AB6032U10; Product Code 2208A055 with Lot AB6291U17 |
| Z-0123-2018 | Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.; Product Code 22714186 with Lot AB6088U01 |
| Z-0124-2018 | Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.; Product Code 220123568 with Lot AB6151U08, AB6207U13 |
| Z-0125-2018 | NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.; Product Code 2V22108147 with Lot AB6018U07 |
What to do — step by step
Check Product Codes
Identify if your suction system has product codes 22012356 with Lot AB6032U10 or 2208A055 with Lot AB6291U17.
Where it went and when
Where it was distributed
Distributed in 37 states and Puerto Rico.
FDA distribution: “Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.9 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.
Questions people ask
Do I need to stop using the system immediately?
The recall does not require immediate stop use; check product codes to determine if affected.
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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-0122-2018 (October 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0122-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.