CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report

Synaptive Trackable Suction Set Standard and Malleable recalled

Synaptive Medical is recalling Synaptive Trackable Suction Set Standard and Malleable, distributed nationwide in the US. The recall was initiated on 23 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSet and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers.

Quantity recalled1291 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1955-2021
FDA event ID: 87937
Recalling firm: Synaptive Medical, Toronto, N/A
Classification: Class II
Status: Terminated
Recall initiated: 23 Apr 2021
FDA classified: 25 Jun 2021
Reported: 7 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

23 Apr 2021	Recall initiated by company
25 Jun 2021	Classified by FDA	+63 days
7 Jul 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Synaptive Trackable Suction Set Standard and Malleable

Where it was distributed

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

Nationwide California Florida Indiana Louisiana Maryland Michigan North Carolina Nevada New York Oregon Pennsylvania South Carolina Texas Virginia Wisconsin

Questions about this recall

Is Synaptive Trackable Suction Set Standard and Malleable recalled?

Yes. Synaptive Medical recalled Synaptive Trackable Suction Set Standard and Malleable on 23 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1955-2021.

Why was it recalled?

Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

Which lots are affected?

Set and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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