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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.
Becton Dickinson is recalling BBL Port A Cul tubes with Swabs Sterile Pack because excessive oxidation may affect the viability of anaerobic microorganisms.
Philips Medical Systems is recalling 110 iCT SP UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Vilex, Inc. is recalling 4 units of FUZE 10.0 mm x 250 mm ankle arthrodesis screws due to a higher-than-expected incidence of breakage.
Smith & Nephew is recalling 17 units of the R3 Constrained Liner because the locking groove is oversized, potentially preventing the locking ring from engaging.
Philips is recalling 25 Brilliance CT 6 Slice Air UPS accessories due to risks of battery acid leakage, overheating, and fume emission.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.
Philips is recalling 156 Ingenuity CT Uninterruptible Power Supply (UPS) accessory devices due to a risk of battery acid leakage, overheating, and fume emission.
Ortho-Clinical Diagnostics is recalling 45 enGen Laboratory Automation Systems worldwide because recapper caps may fall off or tubes may be dropped, risking bio-hazardous fluid splashing and cross-contamination.
Philips Medical Systems is recalling 847 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 17 Brilliance CT 40 Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.
Philips is recalling 10 Gemini LXL 16 Slice CT systems worldwide due to UPS accessory defects that may cause battery acid leakage, overheating, or fumes.
Philips is recalling 11 MX 16 Slice Phase II CT systems because their UPS accessory devices may leak battery acid, overheat, or emit fumes.
Philips Medical Systems is recalling two Diamond Select Brilliance CT 16 systems due to a risk of battery acid leakage, overheating, and fumes from the UPS accessory.
Philips Medical Systems is recalling 71 GEMINI TF PET/CT 64 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Remel Inc is recalling specific lots of Blood Agar plates due to potential Listeria monocytogenes contamination. The products were distributed nationwide.
Gyrus Acmi is recalling Diego Elite Tubesets due to a potential lack of sterility assurance. The recall affects 12,020 boxes distributed in the US, Canada, and other countries.
Smiths Medical is recalling 6,000 units of Low Volume Extension Sets because under-sized tubing was used in production. The affected product was distributed to five states.
Philips Medical Systems is recalling 337 BrightView XCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 288 Ingenuity Core 128 UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Biomet France is recalling three Optigun Ratchet cement guns because a pin may disconnect and be lost, potentially delaying surgery or requiring revision.
Philips Medical Systems is recalling 126 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling AXIS Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 11 Forte-JetStream AZ UPS accessory devices used in CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.
HeartWare Inc is recalling HVAD systems due to complaints of discolored and cracked driveline outer sheaths. The recall affects 3,747 units currently in use.
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