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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.
GE Healthcare is recalling specific ventilator models due to a potential failure of the caster mounting hardware that could cause the device to fall or tip over.
Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.
Puritan Medical Products is recalling sterile absorbent foam tipped applicators because the shafts may break, preventing adequate patient specimen collection.
GE Healthcare is recalling 472 nuclear medicine systems worldwide because a collimator may fall off during rotation. No injuries have been reported.
Transonic Systems Inc is recalling Hemodialysis Monitors that may display zero or low flow values, preventing accurate measurements during dialysis.
CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose a remote potential for minor burns.
Baxter Healthcare is recalling 75 HomeChoice Pro APD systems because the occluder may have sharp edges or separate, causing system errors or therapy termination.
Smiths Medical is recalling specific lots of 50mL CADD Medication Cassette Reservoirs because they may leak at the sealing area. No serious injuries or deaths have been reported.
Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.
CooperSurgical is recalling NovaPlus infant heel warmers because products without expiration dates may cause minor burns.
Radiometer America Inc. is recalling Crea A and B membranes used with ABL800 FLEX analyzers due to negative drift on quality control during their in-use lifetime.
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.
Materialise N.V. is recalling Signature TKA GDE/MDL Set 04-05 surgical guides because images from a different patient were used for production.
Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.
Med-logics Inc is recalling 360 units of ML 7090 Calibrated LASIK Blades because they do not fit into the AMO Amadeus Metal Blade Holder.
US Infusion is recalling 62,700 Medstream IV infusion sets because they may leak at the Y site. The sets were distributed in six states.
St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.
Sybron Dental Specialties is recalling 172 units of Pinnacle Cure Sleeves because inner packaging is mislabeled, creating a risk of cross-contamination if the sleeves tear.
Siemens Healthcare Diagnostics is recalling specific lots of N Latex IgM reagents because they failed proficiency testing, resulting in low recovery rates for serum samples.
LeMaitre Vascular is recalling 54 units of the Tumescent Catheter Inversion System because they were mislabeled with an incorrect expiration date.
Philips Medical Systems is recalling 71 DuraDiagnost X-Ray systems worldwide due to improper installation risks that could cause equipment to fall or float.
Microport Orthopedics is recalling 17 units of the Evolution Tibial Base knee prosthesis component due to a casting tool issue causing varying retaining wall thickness and keel offset.
Arjo is recalling 1,034 Pressure IQ Evolve mattresses nationwide due to failures that resulted in pressure ulcers.
Siemens Healthcare is recalling capillary caps for RAPIDLyte blood collection devices because they may not attach properly, causing glass capillaries to break.
GE Healthcare is recalling Proteus XR/a X-ray systems because a steel cable supporting the bucky device may break. A falling bucky could injure a patient or operator.
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