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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.
Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.
Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.
Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.
ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.
Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.
Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.
A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.
Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.
Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.
Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.
Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.
Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
Medline is recalling 1,770 Peripheral Blood Culture Draw kits because components within the kits have expired before the kit's stated expiration date.
Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.
The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.
A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.
Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.
Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.
Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.
Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.
Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.
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