Tampax Pearl Plastic Applicator Tampons, Scented and Unscented

• • Ongoing Z-1182-2026 FDA Class II ·initiated 26 Dec 2025 ·on shared 510(k) K081555

  Potential exposure of rodents and rodent activity in the distribution center.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K081555 ↗

FDA Product Code

HIL

Device Class

Class II

Regulation

21 CFR Part 884.5460

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Rely Tampon

  Class II

  FDA 510(k) K761184 Active Cleared 17 Dec 1976

• Unscented Menstrual Pad

  Class I

  FDA 510(k) K834144 Active Cleared 29 Dec 1983

• Tampax Compak Pearl Plastic Applicator Scented and Unscented Tampons

  Class II

  FDA 510(k) K062638 Active Cleared 22 Nov 2006

• Always Super Maxipad-Scented

  Class II

  FDA 510(k) K850939 Active Cleared 14 May 1985

• Always Menstrual Pads

  Class I

  FDA 510(k) K071827 Active Cleared 20 Sep 2007

• Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)

  Class II

  FDA 510(k) K040999 Active Cleared 9 Jul 2004

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