The Recall Desk
HighFDA (Devices)·Z-1955-2021·Announced 2021-07-07

Synaptive Suction Sets Recalled for Metal Burrs on Tube Interior

Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a manufacturing defect (visible burrs and metal filings) presenting a risk of surgical field contamination or injury during use. No illnesses or injuries have been reported.

Plain-English summary

Synaptive Medical Inc is recalling 1,291 units of Synaptive Trackable Suction Set Standard and Malleable. The recalled sets are identified by product codes including SYN-0657, SYN-0783, and multiple consumable codes (SYN-0663 through SYN-0668, SYN-0759 through SYN-0766, SYN-0651 through SYN-0677, and SYN-0778). All lot numbers and serial numbers of these sets are affected.

The recall was issued due to visible burrs and metal filings found along the inner perimeter of the suction tubes. These defects could potentially contaminate the surgical field or cause injury during use.

The affected suction sets have been distributed domestically across multiple U.S. states including California, Florida, Indiana, Louisiana, Maryland, Michigan, Nevada, New York, North Carolina, Oregon, Pennsylvania, South Carolina, Texas, Virginia, and Wisconsin. International distribution includes Australia, Belgium, Canada, Netherlands, Singapore, Switzerland, Thailand, United Kingdom, and Vietnam.

If you have received affected suction sets, contact Synaptive Medical Inc or your medical supply distributor for instructions on return or replacement.

The recalled product

Product
Synaptive Trackable Suction Set Standard and Malleable
Manufacturer
Synaptive Medical Inc
Category
Medical Device — Surgical Instruments
Hazard
  • metal-burrs
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 15 states:

  • CA
  • FL
  • IN
  • LA
  • MD
  • MI
  • NC
  • NV
  • NY
  • OR
  • PA
  • SC
  • TX
  • VA
  • WI

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