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.
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.
The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.
DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.
Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.
DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.
Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.
Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.
Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.
Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.
Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.
The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. No injuries have been reported.
Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.
DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.
DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.
Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.
Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.
Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).
CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
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