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.
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 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
- Affected units
- 680
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
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 →Related recalls
Same manufacturer · Argon Medical Devices, Inc
See all →- HighPeripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk
FDA (Devices) · 2026-08-05
- HighMidline Catheter Recalled Over Risk of Leaking or Cracking at Hub
FDA (Devices) · 2026-08-05
- SevereGeneral Biopsy Tray with Lidocaine HCL Injection subject to sterility recall
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighBone Marrow Biopsy Tray with Lidocaine Hydrochloride Recalled for Temperature Abuse
FDA (Drugs) · 2022-06-15
- SevereArrow access tray MC3 contains drugs from a recalled supplier
FDA (Devices) · 2026-06-24
- HighIntegra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate
FDA (Devices) · 2015-11-04
- HighArgon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk
FDA (Devices) · 2015-07-29
- HighArgon Medical Devices Recalls T-LOK Bone Marrow Biopsy Needles
FDA (Devices) · 2017-02-22
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08