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.
The Medline Hernia Repair Tote convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits for breast imaging, plastics and facial procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 2,101 units affected.
Medline central venous catheter insertion kits and Vantex PI CVC bundles are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
Allia IGS Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on.
Allia IGS 5 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. 121 units affected.
Medartis APTUS 5.0 headed cannulated compression screws for bone fixation are being recalled because the cannulation of the screw is not centered. 13 units are affected.
Plum Duo Infusion Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.
MIC Safety PEG Kits with ENFit Connectors, 14 Fr PULL, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall for quality issues.
Fresh Roast Systems ColorTrack instruments, model BENCH R-100, are being recalled because a manufacturing defect could allow access to infrared laser light above the product's safety classification.
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.
MIC Safety PEG Kits, 20 Fr PUSH OTW, catalog number 7170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 901 kits affected.
Merlin Patient Care System programmer software is being recalled because a malfunction during a pacing capture threshold test may stop the command to terminate the test being communicated.
Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.
Bicarby Dialysate, model RFP-400-G, is being recalled because of an error in the GTIN printed on the product, which could lead to a potassium concentration differing from the prescription.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 43 kits affected.
Hintermann Series Talar Implants, Left, Size 2, are being recalled because packaging and labeling for a left implant contained a right implant device. 67 units are affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6316, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 54 kits affected.
Allia IGS 7 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. 35 units affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Looking for a different category? Browse all recalls.