cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Immunotech A.S. Recalls Estrone RIA Kit Over False Results Hazard

Immunotech A.S. recalled 160 Estrone RIA kits on December 15, 2025, due to a risk of falsely high patient results. This class II recall affects kits distributed in multiple countries, including the US and several European nations.

Immunotech A.S.
The affected
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Recalls Allura Xper FD20 Biplane Over Electrical Hazard

Philips Medical Systems recalled 23 units of the Allura Xper FD20 Biplane on December 15, 2025. The recall affects systems with improperly installed drip trays, posing an electrical hazard. Health providers and patients must stop using the device immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
Read more
Health & Personal Care
HIGH
FDA DEVICE

Broselow Recall: Harmful Dosing Errors in Pediatric Organizer

Broselow recalled 89 units of the BROSELOW FILLED BROSELOW ORGANIZER on December 15, 2025. The product contains harmful dosing errors for critical medications. Healthcare providers must stop using the device immediately.

SunMed Holdings
Product contains
Read more
Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Plum Duo Infusion System Over Speaker Failure

ICU Medical recalled 423 units of the Plum Duo Infusion System on December 15, 2025. Defective primary speakers may fail to produce audible alarms and alerts. This poses a high hazard risk to patients reliant on the device for medication administration.

ICU Medical
ICU Medical
Read more
Health & Personal Care
HIGH
FDA DEVICE

Sysmex America Recalls Tube Sorter Due to Lift Hazard

Sysmex America recalled 44 units of the TS-10/TS-10H Tube Sorter on December 15, 2025. The electromagnetic holding force may disengage, causing unintended movement. Healthcare providers should stop using the device immediately.

Sysmex America
Under specific
Read more