Penner Patient Care, Inc. is recalling 1,339 Penner Pacific Bathing Spas because the devices do not have required Unique Device Identifier (UDI) labels. The recall includes various configurations of the bathing spas distributed nationwide. Without these identifiers, healthcare facilities and the manufacturer cannot effectively track the equipment through the supply chain or in clinical use. No injuries have been reported, and the manufacturer is voluntary initiating this correction to ensure compliance with medical device labeling regulations.
The lack of a Unique Device Identifier (UDI) on medical equipment makes it difficult for facilities to identify, track, and manage devices accurately, which is essential for ensuring patient safety and executing recalls or repairs efficiently.
Recall #: Z-1499-2026; Quantity: 21 units
Recall #: Z-1500-2026; Quantity: 643 units
Recall #: Z-1501-2026; Quantity: 10 units
Recall #: Z-1502-2026; Quantity: 45 units
Recall #: Z-1503-2026; Quantity: 206 units
Recall #: Z-1504-2026; Quantity: 158 units
Recall #: Z-1505-2026; Quantity: 25 units
Recall #: Z-1506-2026; Quantity: 15 units
Recall #: Z-1507-2026; Quantity: 190 units
Recall #: Z-1508-2026; Quantity: 26 units
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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