Recall archive / FDA device enforcement
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B;... — FDA record Z-2090-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) 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
- Recalling firm
- Medline Industries, LP
- Quantity
- 1774 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2090-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23AMG574; 5) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMA829; 6) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMI776; 7) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23EMH095; 8) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23FMI704; 9) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23HMC628; 10) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23IMC652; 11) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 12) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 13) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24IMG516; 14) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 15) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 16) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 17) DYNJRA1979B, UDI-DI: 10198459371950(each), 40198459371951(case), Lot Number: 25FBG333; 18) DYNJRA2608, UDI-DI: 10198459331640(each), 40198459331641(case), Lot Number: 25ELB099; 19) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381; 20) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 13, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- May 7, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.