GEM Coupler Forceps, GEM4183C, packaged individually recallZ-0680-2019 · Baxter Healthcare Corporation · initiated Nov 2, 2018
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential presence of rust on Coupler Forceps (GEM4183C).
FDA root cause category: Process control
What the company is doing
Synovis Micro Companies Alliance (MCS), Inc. a subsidiary of Baxter International Inc., notified customers on about 11/02/2018 via "Urgent Product Recall letter sent via U.S.P.S., first class mail. Instructions included to review inventory for affected product, arrange for return of all affected product to Synovis MCA, complete and return the provided Baxter customer reply form, and notify customers if the affected product was further distributed. General questions can be directed to Synovia MCA at 800-510-3318 or 205-941-0111 Monday through Friday, between 8:00 am and 5:00 pm Central Time.
Recall details
- Recall number
- Z-0680-2019
- Status
- Open, Classified
- Initiated by the company
- Nov 2, 2018
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 123 devices
- Product code
- HTD
- Distribution
- Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia
Product description
GEM Coupler Forceps, GEM4183C, packaged individually.
Code information (models, lots, serial numbers)
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GEM COUPLER Forceps GEM4183CSynovis Micro Companies Alliance, Inc · FORCEPS1 recall4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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