Synaptive Trackable Suction Sets: Metal Filings Risk

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Contact the company & request your remedy

Recalling firmSynaptive Medical Inc555 Richmond St West, Suite 800, N/A · Toronto, N/A N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the affected suction sets to prevent injury from metal filings.

✎ GovInfoNow

Questions people ask

What model numbers are affected?

Model codes SYN-0657, SYN-0783, SYN-0663 through SYN-0766, and SYN-0651 through SYN-0778 are affected.

Are all serial numbers affected?

Yes, all serial numbers are affected.

How can I check if my suction set is recalled?

Check the model codes and serial numbers on your product against the list provided in the recall notice.

Take action

Contact Synaptive

We’ve drafted a message you can send Synaptive to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1955-2021 — Synaptive Synaptive

Hello,

I own a Synaptive that is covered by recall Z-1955-2021 from Synaptive.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Synaptive Medical Inc recalls Synaptive Trackable Suction Set Standard and Malleable

Stop using this now