The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2706-2026·Announced 2026-07-22

General Biopsy Tray with Lidocaine HCL Injection subject to sterility recall

Argon Medical Devices is recalling General Biopsy Tray kits containing Lidocaine HCL Injection because the kits do not meet sterility release criteria.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as Class I. Per the rubric, FDA Class I recalls are never scored below 4. Sterility failure in an injectable medical device presents a significant risk of infection and adverse health consequences.

Plain-English summary

Argon Medical Devices, Inc. is recalling General Biopsy Tray kits (REF: GUTS1000) that contain Lidocaine HCL Injection USP 1% 10mg/mL in 5mL ampules. The kits do not meet the required release criteria for sterility.

The recalled product was distributed nationwide in the United States, including Puerto Rico, as well as to Trinidad and Tobago. The affected product quantity is 1,800 units with the code GUTS1000/20886333001594:00886333001590 and lot expiration date of 3/31/2028.

Patients and healthcare providers who have received this product should not use it. Contact Argon Medical Devices, Inc. for instructions on returns or proper disposal. Consult with your healthcare provider if you have questions about your medical care related to this product.

The recalled product

Product
General Biospy Tray, REF: GUTS1000
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Biopsy / Injectable Device Kit
Hazard
Affected units
1,800

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Argon Medical Devices, Inc 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 6 products in this recall →

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