Agency classClass IIOur severity:High FDA (Devices)·Z-0680-2019·Announced 2019-01-02

Baxter Recalls GEM Coupler Forceps Due to Potential Rust

Baxter Healthcare is recalling 123 GEM Coupler Forceps units because of potential rust on the devices. The recall covers nationwide and international distribution.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is the potential presence of rust, which poses a risk of harm but has not been reported to cause injury in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling 123 units of GEM Coupler Forceps (GEM4183C) due to the potential presence of rust on the devices. The affected products are individually packaged and identified by Product Code 5193-06001-010, Lot Number SP18E129-1307852, Sub-lot Number 90828, and UDI 00844735002850.

The recall was initiated by the U.S. Food and Drug Administration as a Class II recall. The devices were distributed nationwide to 18 states, including California, Florida, and New York, as well as internationally to the United Kingdom, Germany, South Africa, Japan, and Australia.

Healthcare facilities and consumers should stop using the affected GEM Coupler Forceps immediately and contact Baxter Healthcare Corporation for instructions on returning the devices or obtaining a replacement.

The recalled product

Product: GEM Coupler Forceps, GEM4183C, packaged individually.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical Instrument
Hazard: rust
corrosion
Affected units: 123

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 (4)

Product Code 5193-06001-010
Lot Number: SP18E129-1307852
Sub-lot Number: 90828
UDI: 00844735002850

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · rust