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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.
Stryker is recalling Hoffmann II Connecting Rod Micro 3 x 30mm (catalog 50796030) because the rods may crack after cleaning and sterilization. FDA has classified this as Class II.
Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.
Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Argon Medical Devices is recalling certain L-Cath PICC catheters because the hub may leak or crack, potentially causing blood loss, infection, or therapy interruption.
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 150mm due to the potential for the rods to crack following cleaning and sterilization processes.
IsoTis OrthoBiologics, Inc. is recalling OsteoBallast and Ballast bone graft extenders because they may contain less demineralized bone matrix than intended.
Medtronic is recalling EOPA 3D Arterial Cannula 22FR because pinhole leaks may occur during cardiopulmonary bypass, potentially causing hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Permobil is recalling M3 Corpus Power Wheelchairs with firmware version 1.26.2 because the firmware lacks a speed restriction when the seat lift exceeds 50 mm, which may cause falls or tip-overs.
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.
Instrumentation Laboratory is recalling certain GEM Premier 5000 blood analyzer systems because the bar code reader wand may assign patient results to the wrong patient ID.
Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.
Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796060) because they may crack after cleaning and sterilization. The recall covers all lots and about 9,658 units distributed worldwide.
Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.
Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796090) because they may crack after cleaning and sterilization. The FDA classified this as a Class II recall.
Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.
Stryker is recalling Hoffmann II Carbon Connecting Rods (catalog 50796040) because they may crack after cleaning and sterilization.
Windstone Medical Packaging is recalling 24 AMS Heart Cath Tray convenience kits containing Elevaris Lidocaine HCl injection because the lidocaine was recalled for supplier quality issues.
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging is recalling 60 AMS Angio Pack-RX convenience kits (lots 230658, 231173) because the included Elevaris Lidocaine HCl injection was recalled by its manufacturer due to supplier quality issues.
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Terex Utilities is recalling Power Over Fiber Base Modules because the devices lack proper laser certification and contain incorrect safety labeling regarding their laser class.
Windstone Medical Packaging is recalling 100 AMS convenience kits labeled Block Tray - RX, Part Number AMS12414, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Windstone Medical Packaging is recalling 3,378 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP because the lidocaine was recalled due to supplier quality issues.
Medline Industries, LP is recalling specific C-Section convenience kits because they contain Bupivacaine Hydrochloride in Dextrose Injection, USP, which is subject to a voluntary recall due to quality issues.
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