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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.
Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.
C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.
C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.
Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.
Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.
BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.
Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.
DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.
DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.
C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.
DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.
DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.
DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.
DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.
Cardinal Health is recalling Presource Kit laparoscopy surgical packs due to being released without sterility assurance. Affected units may harbor contamination and pose a risk during surgical procedures.
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.
Medline Industries is recalling three sterile surgical procedure packs that were damaged by water, compromising their sterility. The recall affects 342 packs distributed in California.
Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.
The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.
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