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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.
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.
Omega Medical Imaging recalls monitor boom systems where the actuator can separate from the pivot mechanism, allowing the boom to detach. The defect affects units manufactured between October 2012 and July 2019.
GE Healthcare's Universal Viewer Workflow Manager medical imaging software may show the wrong patient's information when third-party reporting applications are used. This data mismatch could cause confusion during medical procedures.
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.
Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
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