Circuit, Breathing (w Connector, Adaptor, Y Piece)
Recall Summary Medline is recalling breathing circuit kits (two models: DYNJ0185290G and DYNJ905567A) used in anesthesia because equipment problems during sterilization may have compromised the sterility of the products. The affected kits were distributed nationwide across all U.S. states and territories.
- Product
- Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
- Reason
- Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e93b23cd-1c4f-4f9f-8c3e-af93b6771190