Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0137-2020·Announced 2019-10-16

Guerbet Recalls Optiray Syringes Due to RFID Formatting Error

Guerbet LLC is recalling 3,860 Optiray syringes because an RFID formatting error causes the injector to read the product as expired, preventing injection.

The agency’s classification

FDA (Drugs): 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 of the product could cause temporary or medically reversible health consequences, or where there is a remote probability of serious adverse health consequences. The specific issue is a functional defect (RFID error) preventing use, rather than a direct contamination or safety hazard, aligning with a Moderate severity rating for a labeling/functional defect.

Plain-English summary

Guerbet LLC is voluntarily recalling 3,860 units of Optiray (ioversol) Injection 68%, 320 mg/mL, packaged in 1-100 mL Ultraject Prefilled Syringes. The recall is due to a labeling issue involving an RFID formatting error. This error causes the Optivantage injector to read the product as expired, which prevents the injection of the product.

The affected lots are L141C and L162A (expiration date 06/2021) and L146DS (expiration date 05/2021). The product was distributed nationwide in the USA. The syringes are manufactured by Liebel-Flarshelm Company, LLC., in Raleigh, NC, and are intended for intra-arterial or intravenous use.

Healthcare providers and consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should not be used with the Optivantage injector due to the RFID error. Users should contact the recalling firm for further instructions on how to return or dispose of the affected units.

The recalled product

Product: OPTIRAY (IOVERSOL)
Brand: OPTIRAY
Manufacturer: GUERBET LLC
Category: Drug — Radiographic Contrast Agent
Hazard: rfid-error
mis-labeling
Affected units: 3,860

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)

Lots: L141C
L162A Exp. 06/2021
L146DS
Exp. 05/2021

UPCs (8)

0300191323521
0300191333957
0300191333872
0300191323958
0300191333902
0300191323873
0300191333780
0300191323903

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GUERBET LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · OPTIRAY

Critical
Optiray Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-08-19

Same manufacturer · GUERBET LLC

See all →

Low
Guerbet Recalls Sodium Chloride Syringes Due to RFID Formatting Error
FDA (Drugs) · 2019-10-16

Same hazard · rfid error