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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
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 model 360020-1EP 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 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 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 models in the 360030 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 model 860010-1L because the device does not bear a unique device identifier.
Abiomed is recalling the Impella RP with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
Abiomed is recalling the Impella RP, product code 0046-0011, because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
Abiomed is recalling the Impella RP Flex with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
B. Braun Medical is recalling 21GA Winged Infusion single packs, model 7A3842, because the needle tip may be dull or blunt, difficult to advance, or may break.
Olympus is recalling all lots of its Single Use Biopsy Valve, model MAJ-210, because of the potential for rubber fragment detachment during use.
Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.
Esaote is recalling five Endocavity ultrasonic probes, model E 3-12, because a potential weakness in the probe body may allow liquid to leak from the casing near the cable.
Aesculap is recalling MINOP Trocar 150 mm with 6.0 mm working channel, model FF399R, because of the potential for the trocar shaft to be too long.
Staar Surgical is recalling seven EVO+ Visian Toric Implantable Collamer Lenses that were labeled as 12.1 mm but are 12.6 mm, creating the potential for excessive vault.
GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client because under certain workflows the patient information shown may not match the images displayed.
B. Braun Medical is recalling 21G x 4.4 cm Winged Infusion devices, model 7B3050, because the needle tip may be dull or blunt, difficult to advance, or may break.
Olympus is expanding a recall of ShockPulse-SE Lithotripsy Systems after finding additional generators with a mis-wired component that adds noise to the power supply output.
Olympus is recalling the ShockPulse-SE Lithotripsy System Generator after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.
Olympus is recalling ShockPulse-SE Lithotripsy System single use probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.
Siemens Healthcare Diagnostics is recalling all lots of the Atellica CH Urine Albumin assay because falsely depressed patient results may occur above the measuring interval.
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