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.
Stryker recalls disposable Spetzler-Malis Bipolar forceps due to expiration date labeling error. Labels show 54-month shelf life but actual shelf life is 36 months.
Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect expiration date. The label states a 54-month shelf life when the actual shelf life is 36 months.
One lot of Contra Gray Soft Turbo Plus dental prophylaxis cups may contain Contra Petite Web LF Soft Purple Cup dental angles instead. The recalled product was distributed in Indiana, Tennessee, and Missouri.
Family Dollar recalls 329,044 units of GoodSense denture cleanser tablets that were stored outside their labeled temperature requirements. Products were sold between June and October 2023 at Family Dollar stores across 24 states.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The label states a 54-month shelf life when the actual shelf life is 36 months.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The product label indicates a 54-month shelf life, but the actual shelf life is 36 months.
Family Dollar recalls 329,044 units of ARC Teeth Whitening Pen sold between June and October 2023 across 22 states due to improper storage outside temperature requirements.
Family Dollar is recalling approximately 329,044 units of Oral B Mouth Sore Rinse 237ML because the product was stored outside of labeled temperature requirements. No illnesses or injuries have been reported.
Pulmonx endobronchial valve devices may have been labeled with a shortened expiration date. The devices are usable until December 8, 2024.
Stryker Corporation is recalling Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. The devices are labeled with a 54-month shelf life but actually expire after 36 months.
Family Dollar is recalling 329,044 units of Fixodent denture cream products due to improper storage outside labeled temperature requirements. No illnesses or injuries have been reported.
Family Dollar recalled 329,044 at-home marijuana test strips (SKU 900752) due to improper storage outside labeled temperature requirements. Products were distributed across 22 states between June and October 2023.
Family Dollar's MEDIC's CHOICE contact lens solution was distributed between June and October 2023 due to storage outside labeled temperature requirements. Approximately 329,044 units were affected across 22 states.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an error in the product label's expiration date. The label indicates a 54-month shelf life when the actual shelf life is 36 months.
Stryker recalls disposable Spetzler-Malis bipolar forceps due to incorrect shelf life labeling. The label states 54 months but the actual shelf life is 36 months.
Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.
Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.
Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.
Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.
Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.
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