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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.
CareFusion V.Mueller GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The recall affects 319 units distributed in the US and internationally.
CareFusion GENESIS sterilization containers did not consistently meet aerosol challenge testing requirements. These containers are used in healthcare facilities to sterilize surgical instruments.
CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.
CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.
Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.
LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.
The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.
Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.
CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and internationally.
Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.
CareFusion Genesis reusable sterilization containers have not consistently passed aerosol challenge testing, which verifies their ability to properly sterilize medical instruments. Approximately 537 units were distributed internationally.
Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.
CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.
Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.
CareFusion 2200 Inc recalls GENESIS sterilization containers (model CD3-7ST, all lots) that have not consistently met aerosol challenge testing requirements required for proper sterilization efficacy.
CareFusion GENESIS sterilization containers have failed aerosol challenge testing for STERRAD sterilization validation. The recall affects 451 units distributed in the US and 17 other countries.
Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.
Tollos is recalling Infection Control (IC) Lifting Straps used with certain Cirrus and Pinnacle ceiling lifts because the straps can break during patient lifts, potentially causing patients or caregivers to be injured by falls.
Altimate Medical is recalling EasyStand Bantam Small and Extra Small standers due to a component defect that may prevent the leg assembly bracket from maintaining the non-supine position. No injuries have been reported.
Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.
Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.
Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.
Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.
Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.
Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.
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