The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2707-2026·Announced 2026-07-22

T-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure

Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did 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: This is an FDA Class I medical device recall. Class I recalls are defined as situations where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. Failure to meet sterility criteria for a medical device intended for injection presents a risk of serious infection.

Plain-English summary

Argon Medical Devices, Inc. is recalling T-Lok Bone Marrow Tray kits (REF: BMT1104STL, BMET1104TL, BMT1104CATL) that contain Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The recall was initiated because the kits failed to meet release criteria for sterility.

The affected kits were distributed nationwide in the United States, including Puerto Rico, and internationally to Trinidad and Tobago. A total of 850 units are involved in this recall.

Customers who have received these kits should stop using them immediately and contact Argon Medical Devices for instructions on return or replacement.

The recalled product

Product
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Bone Marrow Tray / Injection Kit
Hazard
Affected units
850

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 (2)

  • BMET1104TL/20886333007602:00886333007608/11654764(3/31/2028)
  • BMT1104CATL/20886333007763:00886333007769/11650887(11/30/2026)

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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