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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.
Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.
Linkbio Corp. is recalling LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.
Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.
Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.
Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.
Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.
DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.
ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.
Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.
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