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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.
Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.
Medline Industries recalls NICU PICC insertion bundles (50 kits) due to openings in breather pouch seals that compromise sterile barrier integrity. This Class II recall affects units distributed across the United States.
Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.
Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.
Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.
Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.
Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.
Boston Scientific is recalling 16 EKOS Control Unit 4.0 consoles that were shipped without proper instructions for use or with incorrect instructions, creating risk of improper device operation.
MICROVENTION is recalling WEB Detachment Controllers due to an out-of-specification tunnel opening that may prevent proper implant detachment. This defect could delay treatment and cause vessel damage from implant manipulation.
Medline is recalling approximately 160 surgical kits with defective breather pouches showing seal openings, potentially compromising sterility. The recall affects facilities in eight states nationwide.
SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.
Medline Industries is recalling 300 units of Bausch + Lomb Cataract Packs due to breather pouches with seal openings that may compromise sterility. The affected surgical kits were distributed nationwide.
Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.
Baxter Healthcare is recalling the Allen Life Assist Beach Chair due to adhesive on fasteners that may not cure correctly, potentially compromising the device's mechanical integrity during surgical procedures.
Medline Industries is recalling 800 Bausch + Lomb Basic Ophthalmic surgical kits (Lot 22DBN365) for defective breather pouch seals. Opened seals in the packaging compromise the sterile conditions required for surgical procedures.
Rebiscan is recalling Blinq Pediatric Vision Scanners (Model BQ830) because the battery pack may vent and catch fire if a cell voltage drops below 2.5V.
Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.
The BD Nexiva Closed IV Catheter System tip shield may separate prematurely during needle withdrawal, leaving the needle tip exposed. This affects 56,080 units distributed across multiple U.S. states.
Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.
Baxter Healthcare is recalling Simple Clamp surgical positioning equipment because the adhesive may not cure properly, reducing mechanical integrity during use. Affected units were distributed across multiple US states and international locations.
Medline is recalling CVC barrier kits (Lot 22ABT774) due to breather pouches with seal openings that could compromise sterility of the surgical kit contents.
Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.
Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.
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