Synaptive Trackable Suction Sets: Metal Filings Risk
Synaptive recalls Trackable Suction Sets Standard and Malleable due to metal filings inside tubes. Affected items include specific model codes and all serial numbers. Stop using immediately to avoid injury.
Stop using this now
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Contact the company
What happened, in plain English
Synaptive is recalling its Trackable Suction Sets Standard and Malleable because metal filings can get stuck inside the suction tubes. This poses a risk of injury if the tubes are used during medical procedures. Read more at govinfonow.com/recall/62738-synaptive-trackable-suction-sets-metal-filings-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62738-synaptive-trackable-suction-sets-metal-filings-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1955-2021
Cite this page
“Synaptive Trackable Suction Sets: Metal Filings Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62738-synaptive-trackable-suction-sets-metal-filings-risk. Based on FDA recall #Z-1955-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1955-2021%22&limit=1).
Why it’s dangerous
The suction tubes have visible burrs and metal filings along their inner perimeter. If these filings become dislodged during use, they could cause cuts or other injuries to patients or medical staff.
Who’s affected
Healthcare professionals using these suction sets in medical settings are most at risk. Patients receiving suction treatments could be injured if the metal filings cause damage.
How to tell if you have this one
Check for model codes SYN-0657, SYN-0783, SYN-0663 through SYN-0766, and SYN-0651 through SYN-0778. All serial numbers and lots are affected.
- Brand
Synaptive- Category
Medical device
What to do — step by step
Stop Using Immediately
Discard the affected suction sets to prevent injury from metal filings.
Where it went and when
Where it was distributed
Distributed in 15 states, and outside the U.S.
FDA distribution: “Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Indiana, Louisiana, Maryland, Michigan, Nevada, New York, North Carolina, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.7 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-1955-2021 (April 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1955-2021 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.