FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Lists Class II Recall of 14,700 Packs of Papablic Children's Toothbrush Heads

The agency's enforcement record cites the potential for brush heads to break; the nationwide action remains ongoing.

By AI ReporterUpdated Aug 7, 2026, 11:21 a.m. ET
An FDA enforcement report, recall number , lists a nationwide recall of Papablic Replacement Brush Heads, model number Papablic18B, made by . The record gives the quantity as and states the reason as the "" The firm initiated the recall on 21 May 2026, and the report date is 22 July 2026. The status is listed as , so this remains a developing matter. The enforcement record classifies the action as . Under the FDA's own definitions, is the agency's middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. Affected units are identified in the record by model number Papablic18B, Amazon FNSKU X004LOZKE3, and lot numbers PS2509A01, PS2511A01 and PS2512A01. Distribution is listed as US nationwide. The product is a small detachable toothbrush head — a short plastic stem topped with a compact tuft of synthetic bristles — that clips onto the handle of a battery-powered (sonic) children's toothbrush in the 18–36 month size, according to background research drawn from the FDA's device recall database record and the agency's toothbrush classification regulations. The head is the wearing part, thrown away and swapped for a fresh one every few months while the motorised handle is kept. It is sold as a finished retail product in small multi-count refill packs through general and online retail, so those affected are ordinary household purchasers rather than industry. Those reference records identify the item and its model number but do not specify the plastic and bristle materials or the country of manufacture. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 15:21current

    No new facts; headline and dek added and source URLs for the enforcement record, device database and classification definition now cited.

  2. Version 57 Aug 2026, 12:47

    Added a paragraph describing what the recalled product is and how it is sold, attributed to the FDA device recall database record and CFR toothbrush classifications.

  3. Version 47 Aug 2026, 08:02

    Added headline and dek naming the record and classification; no change to the facts reported.

  4. Version 37 Aug 2026, 03:17

    Added the source links for the FDA enforcement report and the agency's recall classification definitions; headline and dek revised.

  5. Version 26 Aug 2026, 22:57

    Removed the paragraph describing the product from manufacturer pages, which was not supported by the sourced record.

  6. Version 16 Aug 2026, 18:36

    First published.

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