Z-1878-2009

Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool...

Name: Z-1878-2009 Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool...
Creator: Luv N' Care Ltd
Published: 2009-07-17
License: https://open.fda.gov/license/

Luv N' Care Ltd / initiated 2009-07-17 / Terminated

FDA source

Luv N' Care Ltd began a recall of Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for... on 2009-07-17. The reason FDA records is "Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1878-2009
Status: Terminated
Initiated: 2009-07-17
Posted: 2009-08-12
Terminated: 2013-02-28
Recalling firm: Luv N' Care Ltd
Product: Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process.
Product code: KKO Ring, Teething, Fluid-Filled
Reason for recall: Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.
FDA root cause: PMA
Action: The firm initiated their recall by telephone and email, and followed with letters to their consignees directing a recall to the consumer level. Consumers are urged to stop using the affected product and discard or return to the place of purchase. Consumers with questions about the recall may contact Luv N' Care, LTD by calling 1-800-256-2399. The firm issued a Press Release on July 17, 2009. Press Release about this recall is located on the website address: http://www.fda.gov/Safety/Recalls/ucm172689.htm.
Quantity in commerce: 546,320 units
Distribution: Worldwide Distribution -- US (states of NY, IA, WI, IL, FL, NE, OH, MI, TX, NY, RI, and VA), Canada, Haiti, West Indies, Surinam, Antilles, Uruguay, Mexico, Bermuda, Canada, Dominican Republic, Dutch West Indies, Bahamas, North Antilles and Paraguay.
Product codes and lots: UPC codes: 48526-00451 Nuby 48526-00452 Nuby 48526-00453 Nuby 48526-00454 Nuby 48526-00455 Nuby 48526-00459 Nuby 48526-00467 Nuby 48526-00472 Nuby 48526-00473 Nuby 48526-00482 Nuby 48526-00483 Nuby 48526-00487 Nuby 48526-00490 Nuby 48526-00519 Nuby 48526-00521 Nuby 48526-87115 Cottontails 48526-91511 Playskool and 48526-91660 Cottontails.

Product code KKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)