Penner Patient Care recalled 643 devices nationwide after the FDA flagged missing unique device identifiers. The recall affects a broad range of Penner Pacific Bathing Spa models. The device lacks a unique device identifier, posing regulatory and traceability concerns. Stop using the device and follow recall instructions from Penner Patient Care or a healthcare provider.
The device does not bear a unique device identifier.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Penner Patient Care, Inc. or your healthcare provider for instructions. Notification method: Letter
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Penner Pacific Bathing Spa devices are medical-grade bathing aids used in healthcare settings to assist patient hygiene. The recall affects many model variants.
The absence of a unique device identifier hinders traceability in events of safety issues or recalls and complicates post-market surveillance.
This recall is not part of a broader industry pattern, according to the available data.
Medical facilities and patients may face delays in tracing or replacing affected devices, with potential impact on device selection and regulatory compliance.
UDI-DI and serial numbers are located on the device's labeling and accompanying documentation.
Replacement or refund timelines vary; expect several weeks to a few months depending on manufacturer operations.
Keep the recall notice, serial numbers, model numbers, photos of labeling, and all correspondence with the manufacturer.
Recall quantity: 643 units. Distribution: US nationwide. Brand: Penner Patient Care. Product: Penner Pacific Bathing Spa. Models/UDI-DI: UDI-DI: 0085007365401; Serial Numbers listed in recall. Recall date: 2025-08-13. Status: Active.
No injuries or incidents have been reported.
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