The Recall Desk
Severity pendingFDA (Devices)·Z-1397-2026·Announced 2026-02-25

Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URE

Pending LLM rewrite. Source: FDA_DEVICE Z-1397-2026.

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) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
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) ACC010499
  • UDI-DI: 10193489845709(each)
  • 40193489845700(case)
  • Lot Number: 25BDB702
  • 2) ACC010499
  • Lot Number: 25BDA228
  • 3) ACC010499
  • Lot Number: 25ADB705
  • 4) ACC010499
  • Lot Number: 24JDA650
  • 5) ACC010499
  • Lot Number: 24IDA403
  • 6) ACC010499
  • Lot Number: 23LDC086
  • 7) ACC010499
  • Lot Number: 23IDB182
  • 8) ACC010499
  • Lot Number: 23HDB786
  • 9) ACC010499
  • Lot Number: 21JDB530

Distribution

Distributed nationwide across the United States.

Related recalls

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