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.
Biofinity Toric Multifocal Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 827 units are affected.
Some DIOX-602 portable x-ray systems in use in the United States do not meet the minimum source-to-skin distance requirement of 18 cm. 530 units are affected.
Estrone RIA kits are being recalled because a specific lot of bovine serum albumin used to manufacture the coated tubes caused falsely increased assay results. 496 units are affected.
Medline IV START KIT LAB DRAW-SH convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 184 units affected.
Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.
BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.
GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Medline blood culture convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 15,700 units affected.
Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
The Ellik Evacuator, model 194, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 11 units are affected.
Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
The Ellik Evacuator Adapter, Locking, model 190-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 5 units affected.
The Glass Body for the 194 Ellik Evacuator, model 190A, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Bridge to Life EasiSlush is being recalled because quarterly dose audits monitoring the gamma sterilization process were not completed on time for three lots in the first quarter of 2024. 4,528 units affected.
The Ellik Latex Bulb, model 194-2, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 48 units affected.
The Tubing for Male Connector 194, Ellik Evacuator, model 190-4, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled because of defects, specifically bubbles and voids, identified during standard finished goods testing. 114,165 lenses affected.
Baxter SIGMA Spectrum Infusion Pump V6 units are being recalled because certain pumps may have an incorrect version of software. 14 units are affected.
The i-view video laryngoscope is being recalled because of the potential for faulty devices as a result of depleted batteries. 2,152 pieces are affected.
Baxter SIGMA Spectrum Infusion Pump V8 units are being recalled because certain pumps may have an incorrect version of software. 28 units are affected.
The NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 516 US units affected.
EMPOWR 3D Knee Tibial Insert E-PLUS units, catalog number 341-10-711, are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units affected.
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