The Recall Desk
Severity pendingFDA (Devices)·Z-1415-2026·Announced 2026-02-25

Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS,

Pending LLM rewrite. Source: FDA_DEVICE Z-1415-2026.

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) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-L
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) CDS982893I
  • UDI-DI: 10889942208050(each)
  • 40889942208051(case)
  • Lot Number: 24IBO240
  • 2) CDS983300J
  • UDI-DI: 10193489425048(each)
  • 40193489425049(case)
  • Lot Number: 21CDB781
  • 3) CDS984243G
  • UDI-DI: 10193489872521(each)
  • 40193489872522(case)
  • Lot Number: 23CBX440
  • 4) CDS984243G
  • Lot Number: 23CBN644
  • 5) CDS984243G
  • Lot Number: 23ABC549
  • 6) CDS984243G
  • Lot Number: 22OBM422
  • 7) CDS984243G
  • Lot Number: 22KBD152

Distribution

Distributed nationwide across the United States.

Related recalls

Same category