Injector And Syringe, Angiographic
- Product
- Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
- Reason
- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bbacd891-118e-4466-8d45-23d67473d686