Medline Convenience Kits: 1) Scc Rf Pain Mgmt, Model Number: Dynj56436a; 2) Scc Rf Pain Mgmt, Model Number: Dynj56436b; 3) Cpnb Setup Tray, Model Number: Dynjra1979; 4) Cpnb Setup Tray, Model N

Recall Summary Medline is recalling five models of convenience kits used for pain management procedures because calibration problems with the sterilization equipment may have compromised the sterility of these products. The affected models are SCC RF PAIN MGMT (DYNJ56436A and DYNJ56436B) and CPNB SETUP TRAY (DYNJRA1979, DYNJRA1979A, and SAMPA0108). Healthcare facilities and providers who use these kits are affected.

Product

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108

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/75914762-be17-4ed4-892e-5986114e695d