Category
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.
Applied Medical Technology is recalling NutraGlide 5 F-6 F x 90 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.
Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.
Becton Dickinson is recalling 29,760 BD Kiestra Isolate Suspension Cuvette Arrays because formatting errors in the 2D barcodes stop the analyser reading the expiration date.
Philips is recalling 41 ProxiDiagnost N90 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
Philips is recalling 42 Precision CRF systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
Philips is recalling 223 DigitalDiagnost C90 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
Accriva Diagnostics is recalling 125 boxes, 3,125 tests, of VerifyNow PRUTest because a device without premarket clearance was incorrectly packaged and distributed.
Miach Orthopaedics is recalling 167 BEAR Implants from a single lot, in an action the record says was limited to sales force trunk stock.
Philips is recalling 284 Radiography 7300 C systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
Philips is recalling 17 CombiDiagnost R90 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
Philips is recalling 12 DigitalDiagnost 4 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
Integra LifeSciences is recalling 5,109 CODMAN Disposable Perforators, 9mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.
Integra LifeSciences is recalling 16,251 CODMAN Disposable Perforators, 11mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.
Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with curved extensions, 12 Fr x 20 cm, over header bag seal integrity.
Zimmer is recalling 63 Dual Mobility Vivacit-E bearings labelled Size G 46 mm because the package contents and label may be commingled with the Size F 44 mm bearing.
Beckman Coulter is recalling 657 UniCel DxI 800 analyzers because defective gantry sub-components can cause a z-axis motion error that halts the analyzer and delays results.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 16 cm, over a potential issue with the seal integrity of the header bag packaging.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 13 cm, over a potential issue with the seal integrity of the header bag packaging.
Prismatik Dentalcraft is recalling 208 Inclusive Titanium Screws because an incorrect titanium screw was packaged with the dental implant.
Beckman Coulter is recalling 2,932 units of SYNCHRON Systems Direct LDL Cholesterol reagent from one lot because it may generate false high results.
Spacelabs Healthcare is recalling 142 Sentinel V11 cardiology information systems because patient demographics may default to a previous patient and test data may be saved under another patient's record.
Beckman Coulter is recalling 80 UniCel DxI 600 analyzers because defective gantry sub-components can cause a z-axis motion error that halts the analyzer and delays results.
Integra LifeSciences is recalling 1,198 TruDi Navigation System Multi Instrument Adapters because certain revision combinations may not meet specified accuracy for locating a device in the anatomy.
Total Joint Orthopedics is recalling 103 Klassic BiPolar Heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
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