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Non-Sterility
This recall involves baby loungers made of a cloth cover with a foam sleeping pad and padded bumper. The baby loungers were advertised as "baby lounger" and "baby nest" and were sold in different printed fabrics and colors, including animal, blue star, cloud, feather, flower, forest, leaf, pink star, polar bear and zoo. "SLEEPING SET" is printed on a tag sewn on the interior of the cover. The recall applies to products purchased on or after June 23, 2022, and consumers should review their Amazon purchase history to determine their purchase date. Consumers who still have the packaging can also review the packaging for a label that states the date of manufacture, marked in the format "LOT: YYYYMMDD." This recall applies to products manufactured with "LOT" markings on the packaging of 20220623 (representing June 23, 2022) or later dates.
The recall includes UncleWu Life infant bath seats. The bath seats are made of molded plastic and were sold in navy and powder blue color combinations with suction cups on the bottom of the seats. The bath seat has a seat back, flat base and a T-shaped handle. A label on the bottom of the bath seat contains: "X002WZ4SCX…UNCLE WU Baby Bath Seat…w air for 6-18 Mos." A label printed on the back of the bath seat lists the model name, date, location of manufacturer and model number YD108. Another label on the back of the seat states the product is not a safety device. A label on the disposable packaging of the bath seat contains: "X002WZ4SCX…UNCLE WU Baby Bath Seat."
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
The recall involves HONEY JOY COMPANY infant swings, models BB5569US-GR in gray and BB5569US-BE in beige, made of metal and plastic with a cloth seat. The swings measure about 28 inches wide by 28 inches high and 24 inches wide. "Babyjoy" is displayed on the front of the swings and on the seat label. The infant swings include a head pillow, five-point restraint system, canopy with hanging toys, a music function and an adjustable seat. The swings can be powered using AAA batteries or an AC adaptor and include a remote control with Bluetooth functionality. The full model number can be found on the packaging, the instructional literature identifies model BB5569 and the product registration card, which consumers may have saved for their records identifies model BB5569US.
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis