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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.
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.
DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.
The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.
McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.
B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.
Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.
Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.
Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.
Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.
McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failure that could compromise the sterile barrier. The recall affects 602,340 units distributed worldwide.
Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.
Baxter Healthcare is recalling the Exacta-Mix 2400 compounding system due to potential leaking valves on ports 1-4 in certain lots. Affected units have lot numbers 60316024 and higher.
The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.
McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.
Mckesson Medical-Surgical is recalling BD Vacutainer urine collection tubes and kits due to facility temperature excursions from June to August 2021 that may have compromised preservative effectiveness. All lots distributed between June 1 and September 30, 2021 are affected.
An EVIS EXERA III Bronchovideoscope was recalled after being used in a veterinary endoscopy procedure before assignment to healthcare facilities. The device presents a potential contamination risk.
Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.
McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.
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