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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.
American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.
American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.
Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.
Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.
Capacitors in Prucka 3 Amplifiers used with CardioLab and ComboLab cardiac systems could fail, causing display oscillations and preventing visualization of heart electrical activity waveforms.
MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.
Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.
Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.
Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, stopping pain signal inhibition.
Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.
Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.
Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.
Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.
BD Pyxis MEDBANK medication cabinets contain power strips not certified to electrical safety standards, potentially exposing users to leakage currents. The recall affects 677 units distributed nationwide.
Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.
Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.
A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.
Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.
Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.
BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.
SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.
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