Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1687-2020·Announced 2020-04-15

Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a labeling mismatch, which is a moderate risk compared to direct contamination or structural failure.

Plain-English summary

Baxter Healthcare Corporation is recalling GEM Microvascular Anastomotic Coupler Devices. These devices are intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

The recall is being issued because the Coupler size labeling of the outer tray may not match the Coupler size labeling of the inner tray. This discrepancy could lead to the use of an incorrect device size during microsurgical procedures.

The affected products are identified by Product Code 511-00200-010; GEM2752, and Lots SP19J09-1401617 and SP19J08-1401480. The devices were distributed worldwide, including nationwide in the United States and in several international countries. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product: GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling

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 (3)

Product Code 511-00200-010
GEM2752
Lots SP19J09-1401617 and SP19J08-1401480

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · mis labeling