Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 51 - 75 of 2,579 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850 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-0261-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480 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-0246-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0273-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640 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-0251-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0279-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430 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-0242-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.	FDA Z-0282-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 8, 2026	Details
ROTOR ASSY-SW41, Reference Number 331362, 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) Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.	FDA Z-0202-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 21, 2026	Details
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034 Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).	FDA Z-0191-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 10, 2026	Details
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106 Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0270-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510 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-0248-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470 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-0245-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X 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-0205-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 14, 2026	Details
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. 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-0130-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660 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-0253-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670 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-0254-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Philips Lumify Diagnostic Ultrasound System Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.	FDA Z-0152-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 24, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610 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-0249-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620 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-0250-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. 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-0125-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/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-0195-2027	Medical Device	High	Oct 28, 2026 Recall: Aug 31, 2026	Details
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400 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-0239-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. 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-0123-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 17, 2026	Details
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.	FDA Z-0280-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 9, 2026	Details
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720 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-0256-2027	Medical Device	High	Oct 28, 2026 Recall: Sep 16, 2026	Details

Showing 51 - 75 of 2,579 product recalls

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Medical Device Recalls Today

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How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

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Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.