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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.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.
Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.
Baxter Healthcare is recalling in-line ventilator adaptors (Optimus Handset 2 module) used in home care. The devices may cause reduced oxygenation or barotrauma when used with Volara systems.
Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.
Baxter Healthcare Corporation is recalling 510 units of 15-liter peritoneal dialysis drain bags that were distributed without required FDA regulatory clearance.
Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.
Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.
Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.
Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.
Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.
MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.
Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.
Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.
MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was distributed in the US and Panama.
Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.
Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.
Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.
Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.
Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.
Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.
BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.
Busse Convenience kits containing medical swabs and sticks have been recalled due to uncertainty about whether the manufacturing test methods used were adequately validated.
Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.
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