Category
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.
3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.
3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.
3M is recalling 769,810 Steri-Drape surgical drapes worldwide due to a defective adhesive liner that is difficult to remove and has caused reported skin injuries.
Whele LLC is recalling the Mighty Bliss Electric Heating Pad (model MB-001) due to burn and electrical shock hazards. The firm has received complaints of burns, shocks, and skin rashes from users.
3M is recalling Steri-Drape surgical drapes because the liner on the adhesive component is difficult to remove without damaging the drape. An increase in adhesive-related skin injuries has been reported for affected lots.
3M is recalling 63,840 units of Steri-Drape surgical drapes worldwide due to reported adhesive-related skin injuries and defective protective liners that are difficult to remove without damaging the product.
Whele LLC is recalling the Mighty Bliss Electric Heating Pad due to burn and shock hazards. The company has received complaints of burns, electrical shocks, and skin irritation.
3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.
3M is recalling Steri-Drape surgical drapes due to a defective adhesive liner that is difficult to remove and may render the drape unusable. Reported adhesive-related skin injuries have been linked to the affected lots.
3M is recalling surgical drapes with defective adhesive components that may cause skin injuries. The adhesive liner is difficult to remove without damaging the product, and increased skin injuries have been reported.
3M is recalling Steri-Drape Large Towel Drapes (REF 1010NS) due to adhesive liner defects that may damage the product and increased reports of adhesive-related skin injuries from affected lots.
3M is recalling 43,200 units of Steri-Drape surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and reported increases in skin injuries.
Whele LLC is recalling approximately 4,034 Mighty Bliss Electric Heating Pads due to burn and shock hazards. The firm received complaints of burns, mild electrical shocks, and skin irritation.
3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from the affected lots.
3M is recalling Steri-Drape surgical drapes (large towel drape, REF 1010) distributed worldwide. The affected drapes have reported adhesive-related skin injuries and a liner that is difficult to remove without damaging the product.
3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.
3M is recalling 504,000 units of Steri-Drape surgical drapes worldwide because the adhesive liner is difficult to remove and may damage the product. Reported cases of adhesive-related skin injuries have been associated with the affected lots.
3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.
Pajunk Medical Systems is recalling PAJUNK Continuous Epidural Trays (Model TAL101, Lot 0001359) because some contain 0.75% Marcaine Spinal instead of the intended 0.9% Sodium Chloride. This medication substitution could lead to improper drug administration during epidural procedures.
Visionsense is recalling 205 units of its VS3 Iridium microscope because optical fiber cables may become damaged during handling, causing loss of function and outer cable heating or melting.
ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to LA, MO, NC, and FL.
ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 90 regard shoulder arthroscopy surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.
Visionsense VS3 Iridium beam combiners may develop damaged optical fiber cables through handling or bending, causing loss of functionality and potential cable heating or melting. Affected units were distributed nationwide in the US.
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