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.
Covidien Mon-a-Therm General Purpose Temperature Probes, REF 90044, are being recalled because the devices lack FDA clearance. 1,775 units are affected.
B. Braun CESK Harris Methodist kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.
B. Braun NES1725KFXL spinal epidural closed tip catheters are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack. 1,730 units affected.
HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants are being recalled due to an incorrect shelf-life expiration date. 36 units are affected.
B. Braun SESK UPMC Double Catheter Trays are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
Covidien Shiley Tracheostomy Tubes with inner cannula, REF 6FEN, are being recalled following a customer complaint about incorrect display box labeling. 1,002 units are affected.
Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.
Medline Industries, LP is recalling specific Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to microbiology testing data integrity concerns and efficacy complaints.
Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to microbiology testing data integrity concerns and efficacy complaints.
Medline pain trays and Whitacre spinal block trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 28,106 kits are affected.
Automated Impella Controllers that have not been through Abiomed's servicing process are pending four hardware updates addressing motor control, startup and pump stop risks.
Medline anesthesia trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 1,100 kits are affected.
The RelayPro Thoracic Stent-Graft System is subject to a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent release of the graft.
Medline spinal trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled over microbiology data integrity and efficacy complaints.
Automated Impella Controllers sold outside the US are being recalled over alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing and purge cassette misalignment.
Medline spinal block trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 30,120 kits are affected.
Medline spinal anesthesia trays containing Huons Bupivacaine HCl in Dextrose Injection are being recalled after that drug was recalled. 200,702 kits are affected.
GE HealthCare is recalling trade-in CARESCAPE Telemetry Servers because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
GE HealthCare is recalling CARESCAPE Telemetry Server V5 ATO models because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
GE HealthCare CARESCAPE Telemetry Servers ARK-2250L are being recalled because a persistent NO COMM or OFF NETWORK condition can cause potential loss of ECG and SpO2 monitoring.
Halyard Purezero Ultraviolet Nitrile Exam Gloves are being recalled because they failed to meet specifications for chemical permeation performance. 452,500 units are affected.
GE HealthCare ApexPro v5.0 Software Disaster Recovery USB Kits are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of ECG and SpO2 monitoring.
GE HealthCare IOU assemblies for the ARK2250 CARESCAPE Telemetry Server are being recalled because a persistent NO COMM or OFF NETWORK condition can cause loss of monitoring.
HydroMARK Breast Biopsy Site Markers are being recalled because boxes labeled as T3 markers may contain individual packages labeled as T4 markers. 1,910 units are affected.
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