Z-1955-2021Class II

Synaptive Trackable Suction Set Standard and Malleable

Name: Z-1955-2021 Synaptive Trackable Suction Set Standard and Malleable
Creator: Synaptive Medical Inc
Published: 2021-04-23
License: https://open.fda.gov/license/

Synaptive Medical Inc / initiated 2021-04-23 / Terminated / root cause: supplier

FDA source

Synaptive Medical Inc began a recall of Synaptive Trackable Suction Set Standard and Malleable on 2021-04-23. FDA classified it as Class II and gives the reason as "Due to visible burrs/metal filings affixed along the suction tube inner perimeter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1955-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-23
Posted: 2021-06-25
Terminated: 2024-01-12
Recalling firm: Synaptive Medical Inc
Product: Synaptive Trackable Suction Set Standard and Malleable
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On April 23, 2021 the firm sent a letter to its consignees with the following instructions: 1. Quarantine and discontinue use of all Synaptive Trackable Suction devices. 2. Contact Synaptive Recall Support at 1.866.853.8001 or by email at [email protected]. Customer service will schedule an on-site inspection of each device. If this is not possible, arrangements will be made to have all impacted units returned to Synaptive. 3. Once on-site inspection or return of your stock has been arranged, please complete and return the attached Acknowledgement and Receipt Form. All forms should be submitted by email to [email protected]. Note: If you are in North America and your account is supported by a Synaptive Clinical Applications Specialist (CAS), then a company representative may have already visited your site and conducted the necessary inspections. If so, we kindly ask that you still complete the Acknowledgement and Receipt Form for our records. 4. Upon inspection, all units will be graded as pass or fail. Units that pass meet normal specifications and are safe for continued use. These devices will be returned and released back into circulation. Failing (i.e. defective) units will be removed immediately and replaced by Synaptive at no cost.
Quantity in commerce: 1291 units
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1955-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1955-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25

Product code GCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)