Argon Medical Devices, Inc: Gauze/sponge, Internal, X-ray Detectable
Recall Summary Argon Medical Devices is recalling Arterial Line Kits (model 400115A) distributed nationwide because the included Lidocaine anesthetic ampules failed sterility testing and do not meet safety standards. The kits were distributed across the U.S., Puerto Rico, Trinidad and Tobago, and all 50 states. This is classified as a Class I recall, indicating a serious potential health risk.
- Recalling firm
- Argon Medical Devices, Inc
- Product
- Arterial Line Kit 20ga x 6, REF: 400115A
- Reason
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ad56b267-75e7-4fcc-8b70-e6e073d2d252