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.
Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.
MEDLINE has recalled certain lots of its Polyurethane Foam Bedside Cleaning Kit due to microbial contamination detected on the foam sponge. Sporadic reports of discoloration were identified as contamination.
Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.
MEDLINE has recalled its Polyurethane Foam Bedside Cleaning Kit (REF DYK500FS) in the United States and Panama after sporadic reports of discoloration. The discoloration has been identified as microbial contamination.
Medline Industries recalls Polyurethane Foam Bedside Cleaning Kits due to sporadic reports of discoloration on foam sponges caused by microbial contamination. The recall affects 22,765 boxes distributed in the US and Panama.
Busse Hospital Disposables is recalling Pump Refill Kits nationwide due to uncertainty about whether manufacturing test methods were properly validated. The recall affects 40 units.
Busse Convenience kits containing swab products are being recalled due to inadequate validation of manufacturing test methods.
Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.
Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Busse Convenience kits containing swab products due to uncertainty about manufacturing test method validation. No illnesses or injuries have been reported.
Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.
Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.
Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.
Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.
Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.
Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.
Busse Hospital Disposables is recalling Busse Convenience Kits containing medical swabs and swabsticks due to uncertainty about test method validation in manufacturing. No illnesses reported.
Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.
Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.
Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.
Busse Hospital Disposables is recalling Single Shot Epidural Trays due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
The FDA is recalling approximately 4,449 Sara Plus Active Floor Lift devices due to a fire hazard. The devices may emit smoke or ignite, posing a risk to users and staff.
Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.
Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.
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