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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.
Regard MAJOR EAR surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida are being recalled because the kits contained 3M surgical drapes that were subsequently recalled.
Southmedic is recalling 450 units of sterile surgical blade cartridges (Lot W92761) because the product was not sterilized but was labeled and distributed as sterile. Non-sterile surgical blades could cause infection if used on patients.
ROi CPS LLC is recalling 302 Regard SPINE surgical convenience kits containing 3M surgical drapes that were subject to an FDA recall. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Regard VITRECTOMY PK surgical convenience kits are being recalled because they contain 3M surgical drapes that were separately recalled. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
American Contract Systems, Inc. is recalling a surgical basin set (MEBS42K) because the kit contents do not match the labeled contents. The mismatch could result in improper surgical preparation.
Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
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.
Allison Medical is recalling 150,000 InControl insulin syringes distributed in Texas due to incorrect package labeling of needle gauge. The mislabeled packages may lead patients to unknowingly select the wrong needle size.
ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The kits were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 170 surgical convenience kits containing 3M surgical drapes that were previously recalled. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC recalls 213 surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
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.
Surgical convenience kits are being recalled because they contained 3M surgical drapes that were subsequently recalled. 177 kits distributed in Louisiana, Missouri, North Carolina, and Florida are affected.
Corin Ltd is recalling the Unity Total Knee System due to potential damage to internal packaging that could compromise device sterility. No injuries have been reported.
ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 326 regard TOTAL JOINT surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contain 3M surgical drapes that were previously recalled. No illnesses or injuries have been reported.
ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling Regard Retinal Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained recalled 3M surgical drapes.
3M is recalling Steri-Drape Small Towel Drapes because the adhesive liner is difficult to remove without damaging the product and has caused reported skin injuries.
ROi CPS LLC is recalling 38 neurosurgery convenience kits distributed in four states because they contain 3M surgical drapes that were separately recalled.
ROi CPS LLC is recalling regard TOTAL HIP ARTHROPLASTY surgical convenience kits containing recalled 3M surgical drapes distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.
Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Smiths Medical's Medfusion 4000 infusion pump software may delay sending infusion start messages to Electronic Health Record systems, potentially affecting infusion programming and clinical documentation.
3M recalls specific batches of Steri-Drape surgical drapes due to reported adhesive-related skin injuries and potential product damage from difficult-to-remove adhesive liners.
ROi CPS LLC is recalling 54 regard LATERAL SHOULDER surgical convenience kits containing 3M surgical drapes that were subsequently recalled by the manufacturer. Affected kits were distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.
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