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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.
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.
Baxter Healthcare is recalling 542 units of the Operating Table TruSystem 7000 U14 worldwide due to reports of electrical short-circuits and smoke emissions from batteries and connectors.
Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.
Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.
Medline Industries is recalling 498,354 units of Centurion CirClamp sterile surgical clamps due to holes in the packaging that may compromise sterility assurance. No illnesses or injuries have been reported.
Baxter Healthcare recalled 24 units of its TruSystem 7000 operating table worldwide due to battery and connector electrical short-circuits and smoke emission.
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.
Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.
Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability to zero the device.
Baxter Healthcare is recalling 6,045 TruSystem 7000 U operating tables worldwide due to battery and connector failures that can cause electrical short-circuits and emit smoke.
Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.
Baxter is recalling its TruSystem 7000 operating table worldwide due to customer reports of battery and connector short-circuits that emitted smoke. All serial numbers are affected.
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.
Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.
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