The Recall Desk
SevereFDA (Devices)·Z-2709-2026·Announced 2026-07-22

Bone Marrow Tray kits recalled due to sterility failure

Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I recall, which per the rubric criteria requires a minimum severity score of 4. Non-sterile injectable medical devices present a serious risk of infection or other adverse health consequences.

Plain-English summary

Argon Medical Devices, Inc. is recalling Bone Marrow Tray kits (REF: CB0033TL; CB0355TLA) containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The kits were recalled because they do not meet release criteria for sterility.

The recalled kits were distributed nationwide in the United States, including Puerto Rico, and overseas to Trinidad and Tobago. A total of 680 units are affected.

Patients and healthcare providers in possession of affected kits should stop using them. Consult with healthcare providers regarding appropriate medical follow-up. Affected units may be returned to the manufacturer.

The recalled product

Product
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Bone Marrow / Injectable
Hazard
  • sterility-failure
  • contamination

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)

  • 11652276(3/31/2028)
  • CB0355TLA/20886333217698:00886333217694/11651977(3/31/2028)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category