Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 101 - 125 of 2,579 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0259-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0237-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0227-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.	FDA Z-0194-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 31, 2026	Details
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030 Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.	FDA Z-0267-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 8, 2026	Details
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0260-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471) Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to biohazardous materials.	FDA Z-0201-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 21, 2026	Details
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.	FDA Z-0206-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 14, 2026	Details
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " Simplera sensor " Instinct sensor " InPen smart insulin pen " Apple Watch [Optional] Continuous glucose monitoring (CGM) is a technology that allows you to continuously view glucose values. The app uses an inserted Simplera sensor CGM or Instinct sensor CGM with Bluetooth¿ wireless technology that converts small amoun A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose. The issue was caused by a type cast exception during database migration that occurs upon app update to version 1.2.1 causing a silent failure that prevented the creation of new alerts. Failure to receive the long-acting dose reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, inadvertent duplicate dosing may occur, potentially resulting in hypoglycemia.	FDA Z-0265-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 2, 2026	Details
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml) Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.	FDA Z-0200-2027	Medical Device	High	Oct 28, 2026 Recall: Jul 29, 2026	Details
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.	FDA Z-0131-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
MEDLINE medical convenience kits labeled as (list truncated) Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0275-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.	FDA Z-0196-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 31, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0229-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.	FDA Z-0132-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B. Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0281-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.	FDA Z-0197-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 31, 2026	Details
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.	FDA Z-0127-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0231-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer DNA or RNA sequencing system software has vulnerabilities.	FDA Z-0211-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 14, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0258-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0243-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	FDA Z-0232-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.	FDA Z-0155-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 21, 2026	Details
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100. 4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000. 5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000. 6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000. 7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000. Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.	FDA Z-0142-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 24, 2026	Details

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Medical Device Recalls Today

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