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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.
ROi CPS LLC is recalling 790 neuro surgery convenience kits that contained 3M surgical drapes which were subsequently recalled. The kits were distributed to Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.
3M is recalling 84,000 units of Steri-Drape surgical drapes because the adhesive component's liner is difficult to remove without damaging the product, and there have been reported adhesive-related skin injuries.
Hamilton-C6 ventilators are subject to a backlight malfunction causing the display screen to go black for 2-3 seconds. The FDA has classified this Class II recall as affecting 443 U.S. systems distributed nationwide.
Cataract eye surgery convenience kits containing recalled 3M surgical drapes were distributed to four states. ROi CPS LLC has recalled 780 units of the regard CATARACT product.
ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.
Visionsense, Ltd. issued a voluntary Class II recall of the VS3 Iridium infrared fluorescence microscope affecting 34 units with US Nationwide distribution.
ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.
ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.
ROi CPS LLC is recalling 20 surgical convenience kits distributed in LA, MO, NC, and FL because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.
Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.
Endo-Therapeutics is recalling 28 eSuction Small Cavity Model ET2005 devices distributed in Florida and Pennsylvania due to improper regulatory classification.
ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.
Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.
Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.
Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.
Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.
Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.
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