Penner Patient Care recalls 190 Bathing Spa devices nationwide after discovering the units lack a unique device identifier. The issue involves missing UDI on the device. Stop using the device immediately and follow the recall instructions.
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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The Bathing Spa is a health-related device used for patient care. It is distributed nationwide and listed under Penner Patient Care.
Lack of a unique device identifier complicates tracking and adverse event reporting, though the immediate safety risk is not described as physical injury.
This recall is not described as part of a broader industry pattern.
The recall creates potential confusion for clinicians and patients and may affect post-market surveillance.
UDI and serial numbers are shown in the product documentation and on the device label
Remediation details are provided by the manufacturer; no public refund timeline is provided
Keep all recall notices, correspondence, and device documentation for records
Model Numbers 760010-1 and 770010-1. Quantity: 190 units. Distribution: US nationwide. Sold by unknown retailers. Recall date: 2025-08-13. Report date: 2026-03-18. Brand: Penner Patient Care.
No specific injuries or adverse events are detailed in the provided recall notice.
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