Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Mod
Pending LLM rewrite. Source: FDA_DEVICE Z-1386-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNJ56436A
- UDI-DI: 10889942749874(each)
- 40889942749875(case)
- Lot Number: 21BMC737
- 2) DYNJ56436A
- Lot Number: 21AMB799
- 3) DYNJ56436B
- UDI-DI: 10193489869569(each)
- 40193489869560(case)
- Lot Number: 21DME244
- 4) DYNJRA1979
- UDI-DI: 10195327186852(each)
- 40195327186853(case)
- Lot Number: 22IBU628
- 5) DYNJRA1979
- Lot Number: 22GBV936
- 6) DYNJRA1979A
- UDI-DI: 10195327649258(each)
- 40195327649259(case)
- Lot Number: 25DME153
Distribution
Distributed nationwide across the United States.
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