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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.
Teleflex is recalling Slick Set Cuffed Endotracheal Tubes because the 15mm connector may disconnect from the tube. The recall affects 1,460 units distributed nationwide, including Puerto Rico.
TELEFLEX is recalling 3,310 units of Slick Set Uncuffed Endotracheal Tubes (REF 170155) distributed nationwide due to reports of the 15mm connector disconnecting from the tube.
Teleflex is recalling Slick Set Uncuffed Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. The recall affects 14,160 units distributed nationwide.
Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.
Teleflex endotracheal tubes with high-volume, low-pressure cuffs are recalled due to reports of 15mm connector disconnection. The recall affects 13,810 units distributed nationwide.
Teleflex is recalling 12,400 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets nationwide due to reports of 15mm connector disconnection. The affected batches and lot numbers are identified above.
Teleflex is recalling 670 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube.
TELEFLEX is recalling 5,990 endotracheal tubes due to reports of 15mm connector disconnection. Affected units were distributed nationwide, including Puerto Rico.
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of connector disconnection. The affected devices may disconnect during use, potentially compromising airway management.
TELEFLEX LLC is recalling 6,710 endotracheal tubes due to reports of 15mm connector disconnection. This Class I recall affects units distributed nationwide.
Teleflex is recalling 347,422 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The connector may separate from the tube during use.
Teleflex is recalling 32,553 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide due to reports of 15mm connector disconnections that could compromise airway management.
Teleflex is recalling Slick Set Cuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube, affecting airway management in critical care settings.
Teleflex is recalling 3,309 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This defect may compromise airway management during medical use.
TELEFLEX is recalling approximately 43,571 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection from the tube, affecting nationwide distribution including Puerto Rico.
TELEFLEX LLC is recalling 300,613 endotracheal tubes due to reports of 15mm connector disconnection. The affected tubes were distributed nationwide and could pose patient safety risks.
TELEFLEX LLC is recalling 3,031 Endotracheal Tube units due to reports of 15mm connector disconnection. The affected Magill model (REF 100380045) was distributed nationwide.
TELEFLEX LLC recalls 2,520 endotracheal tubes (model REF 112080055) due to reports of 15mm connector disconnection. The disconnection could compromise airway function during critical care use.
TELEFLEX is recalling 5,600 endotracheal tubes nationwide due to reports of 15mm connector disconnection that could compromise airway management during patient care.
A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.
Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.
Hologic's Sertera 14 Gauge Biopsy Device may experience inner needle detachment or discharge during use, which could delay breast biopsy surgery. The company is recalling 756 units nationwide.
Baxter's Voalte Patient Safety software may permanently stop sending caregiver alerts for critical patient protocols like bed exit and siderail changes. Affected versions V4.0.000 through V4.0.401 are used with Centrella Beds.
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.
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