FDA (Devices) recall action 98396
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
The device does not bear a unique device identifier.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Penner Patient Care is recalling Pacific Bathing Spa models in the 350010 series because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa models 390010-1, 390010-X and 390010-2 because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa models in the 361910 series because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa models in the 360030 series because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa models 760010-1 and 770010-1 because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa models in the 560010 series because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa model 360020-1P because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa models across the 360010, 362010 and 370000 series because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa model 860010-1L because the device does not bear a unique device identifier.
Penner Patient Care is recalling Pacific Bathing Spa model 360020-1EP because the device does not bear a unique device identifier.