Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-05-27FDA-DeviceICU Medical, Inc.Class IIICU Medical ChemoLock oncology sets recalled for leak risk
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- 2026-05-27FDA-DeviceTANGENT ENDOSCOPY, LLCClass IITangent Single Use Digital Catheter recalled for shaft fracture
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- 2026-05-27FDA-DeviceBecton, Dickinson and CompanyClass IIBecton Dickinson Swan-Ganz catheter recalled for hub leak risk
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
- 2026-05-27FDA-DeviceBecton, Dickinson and CompanyClass IIBecton Dickinson Swan-Ganz Jr Catheter recalled for leak risk
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
- 2026-05-27FDA-DeviceBecton, Dickinson and CompanyClass IIBecton Dickinson Swan-Ganz catheters recalled for leak risk
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
- 2026-05-26FDA-PROmnipod insulin pods recalled for under-delivery risk
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identif
- 2026-05-20FDA-DeviceMedtronic NeuromodulationClass IIMedtronic SynchroMed programmer software recalled for scheduling error
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- 2026-05-20FDA-DeviceMICROVENTION INC.Class IIMicroVention LVIS stent recalled for sizing defect risk
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIMedtronic Marinr catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheters recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheters recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIDaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheters recalled for incomplete seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker Daig Livewire catheters recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker electrophysiology catheter recalled for seal defect
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker electrophysiology catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker electrophysiology catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker BARD EP XT catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker BARD EP XT catheters recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker BARD Dynamic XT catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker BARD Dynamic XT catheter recalled for incomplete sterile seals
Incomplete seals on sterile product
- 2026-05-20FDA-DeviceStryker Sustainability SolutionsClass IIStryker BARD Dynamic XT catheters recalled for incomplete seals
Incomplete seals on sterile product
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