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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.
Mozarc Medical is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack units due to a potential breach in sterile barrier packaging that could compromise the product's sterility.
Silex Medical is recalling 8 units of Signature Laparoscopic Debakey Grasper instruments (Model 5862100) due to incomplete insulation on the shaft near the rotator wheel, which could expose the user or patient to electrical contact.
Beckman Coulter is recalling the Access Testosterone assay (Catalog Number 33560) due to inadequate maintenance on manufacturing equipment that caused cross-contamination in testosterone reagent packs, which could result in inaccurate patient test results.
Luminex is recalling VERIGENE Gram Negative Blood Culture test cartridges due to a consumable issue that may produce incorrect results on a small portion of one lot.
Mozarc Medical is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. The affected catheter models were distributed nationwide in the US and in Canada and Mexico.
Silex Medical is recalling the Signature Laparoscopic Alligator Grasper with Rotating Shaft (Model 5863050) because insulation on the tube does not fully extend to the proximal end of the shaft, leaving an exposed uninsulated area near the rotator wheel.
Silex Medical is recalling 2 units of a Signature Laparoscopic Instruments Dolphin Nose Grasper with Rotating Shaft due to incomplete insulation on the shaft, leaving an exposed area near the rotator wheel.
Dexcom G7 iOS App version 2.7.0 can enter a state where glucose readings freeze and alerts do not trigger, risking missed detection of dangerously high or low blood sugar. Other connected devices like Apple Watch and insulin pumps continue to receive glucose data directly from the transmitter.
Silex Medical is recalling Signature Laparoscopic Atraumatic Grasper instruments (Model 5864000) due to incomplete insulation on the shaft that leaves an exposed area near the rotator wheel, posing an electrical safety risk during surgical use.
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.
Beckman Coulter is recalling sample probes with defective tips used in clinical chemistry analyzers. The defective probes may dispense lower sample concentrations, potentially leading to false low test results and delayed diagnosis.
Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.
Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.20 because the update introduces error codes that prevent assays from being performed and may delay result generation.
Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.
Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.
Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.
Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.
Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.
Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.
Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.
Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.
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