Medline Convenience Kits: 1) Arthroscopy Cds, Model Number: Cds984609b; 2) Arthroscopy Trays, Model Number: Dynj22501g; 3) Arthroscopy Pack, Model Number: Dynj32715f; 4) Chs Arthroscopy Pack, M
Recall Summary Medline is recalling five arthroscopy surgical kits (including trays, packs, and related equipment) because equipment used to sterilize and package them may not have been properly calibrated. While the products went through sterilization and packaging processes, the calibration problems could affect whether the devices are adequately sterilized and safe to use. This recall affects healthcare facilities and surgical centers that received these specific Medline arthroscopy products.
- Product
- Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
- 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 II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2231126f-e16f-437b-8c1e-28b1e4f58ed9