Medical device recalls
2,647 federal recalls in the last 12 months. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck your Burlington Medical frontal apron
Burlington Medical is recalling certain frontal aprons (radiation protection garments) with Xenolite 800 shielding material made between January 2025 and January 2026. The material may degrade over time, reducing its ability to protect against radiation exposure. No injuries have been reported.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck your Burlington Medical Kilt model
Burlington Medical is recalling certain Kilt models because the Xenolite 800 attenuation material used in them may break down over time, reducing how long the product lasts. The recall affects units made between January 16, 2025 and January 21, 2026.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck Burlington Medical vest serial number
Burlington Medical protective vests made with Xenolite 800 attenuation material between January 16, 2025 and January 21, 2026 may weaken over time, reducing their protective lifespan. No injuries have been reported. The company is notifying users and working on a remedy.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck your Burlington Medical Thyroid Shield
Burlington Medical thyroid shields manufactured between January 16, 2025 and January 21, 2026 contain attenuation material that may degrade over time, reducing the shield's protective effectiveness. This affects multiple model numbers and sizes.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your Medtronic MiniMed insulin pump positioning
Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is held higher or lower than the infusion site on your body. This happens because gravity affects the pressure inside the pump tubing. Incorrect insulin doses can cause serious blood sugar problems.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IIStop using affected Medtronic MiniMed insulin pumps
Medtronic MiniMed insulin pumps (including Paradigm, 600, and 700 series models) may deliver too much or too little insulin when the pump is positioned above or below the infusion site. This happens because gravity affects how insulin flows through the tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your Medtronic MiniMed insulin pump position
Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is held above or below the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and other serious complications.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IIStop using Medtronic MiniMed Paradigm insulin pump
Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is held at different heights relative to the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and serious complications.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IIStop using affected Medtronic MiniMed insulin pumps
Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is positioned higher or lower than your infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and other serious complications.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IIStop using affected Medtronic MiniMed insulin pumps
Medtronic MiniMed infusion pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is raised or lowered relative to the infusion site. This happens because gravity affects pressure in the pump system. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and serious complications.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your Medtronic MiniMed insulin pump position
Medtronic MiniMed insulin pumps (including 740G, Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is positioned higher or lower than the infusion site on your body. This happens because gravity affects the pressure inside the pump tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IIStop using Medtronic MiniMed insulin pumps
Medtronic MiniMed insulin pumps (including MiniMed 720G, Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is positioned above or below the infusion site. Too much insulin can cause dangerously low blood sugar, while too little can cause dangerously high blood sugar.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your Medtronic MiniMed insulin pump position
Medtronic MiniMed insulin pumps (including Paradigm, 600 series, and 700 series models) may deliver too much or too little insulin depending on whether the pump is held above or below the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and related complications.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your MiniMed insulin pump positioning
Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump height changes relative to the infusion site. When elevated, excess insulin may cause dangerously low blood sugar. When lowered, insufficient insulin may cause dangerously high blood sugar. This affects about 116,000 pumps worldwide.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your MiniMed 770G pump position during use
Medtronic MiniMed insulin pumps may deliver too much or too little insulin depending on whether the pump is held above or below the infusion site on your body. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar. This happens because gravity affects how insulin flows through the pump.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your MiniMed 780G pump position during use
Medtronic MiniMed insulin pumps (including the 780G model and older Paradigm and 600 series) may deliver too much or too little insulin when the pump is held higher or lower than the infusion site on your body. This happens because gravity affects how insulin flows through the tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IIStop using affected Medtronic MiniMed insulin pumps
Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is positioned higher or lower than your infusion site. This happens because gravity changes the pressure inside the pump. Too much insulin can cause dangerous low blood sugar; too little can cause dangerous high blood sugar and other complications.
- 2026-04-08FDA-DeviceMedtronic MiniMed, Inc.Class IICheck your MiniMed 670G insulin pump position
Medtronic MiniMed insulin pumps can deliver too much or too little insulin when the pump is positioned higher or lower than the infusion site on your body. This happens because gravity affects the pressure inside the pump tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using affected Civco eTRAX needle sensors
Civco Medical Instruments Co. Inc. is recalling certain eTRAX Needle Sensor 18G units used with Aurora Trackers due to an inspection and programming error. This error can cause the needle tip position to display incorrectly on the user interface, potentially affecting procedure guidance.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle Sensor
Civco Medical Instruments has recalled certain eTRAX Needle Sensors (16G, Part Number 667-158) used with Aurora Trackers due to a programming error during manufacturing. The sensor may display an incorrect needle tip position on the user interface, which could affect proper guidance during procedures. The recall affects 10 units distributed in Ohio, Pennsylvania, Washington, and China.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle Sensor 14G
Civco Medical Instruments discovered a programming error in certain eTRAX Needle Sensors (14G) used with Aurora Trackers. This error can cause the needle tip position to display incorrectly on the screen, which may affect accurate needle placement during procedures.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle Sensor 12G
Civco Medical Instruments Co. Inc. recalled the eTRAX Needle Sensor 12G (Part Number 667-156) used with Aurora Trackers due to an inspection and programming error. The sensor may incorrectly display the needle tip position on the user interface, which could affect clinical accuracy during procedures.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle System Starter Kit
Civco Medical Instruments Co. Inc. is recalling certain eTRAX Needle System Starter Kits (18G) used with Aurora Trackers due to a manufacturing error. The needle sensor may not correctly show the needle tip position on the display, which could affect proper use of the device.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle System Starter Kit
Civco Medical Instruments identified a programming error in certain eTRAX needle sensors used with Aurora trackers. This error can cause the needle tip position to display incorrectly on the user interface, which may affect the accuracy of needle placement guidance.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle System Starter Kit
Civco Medical Instruments has recalled the eTRAX Needle System Starter Kit 14G due to a manufacturing error in the needle sensor for Aurora Trackers. The error may cause the needle tip position to display incorrectly on the device screen, which could affect proper placement during procedures.
- 2026-04-08FDA-DeviceCivco Medical Instruments Co. Inc.Class IIStop using Civco eTRAX Needle System Starter Kit
Civco Medical Instruments identified a programming error in the eTRAX Needle System Starter Kit 12G (Part Number 667-149) for Aurora Trackers. This error can cause the needle tip position to display incorrectly on the user interface, potentially affecting procedure accuracy. Two units were affected and distributed to Ohio, Pennsylvania, and Washington.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IIStop using Medline Anterior Hip Pack DYNJ64672B
Medline's Anterior Hip Pack surgical kits contain Olympus biopsy valves that may shed rubber fragments. These fragments could lodge in a patient's airway during a procedure, potentially requiring removal and causing breathing problems or inflammation.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IIMedline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTO
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IIStop using affected Medline bronchoscopy kits
Medline kits containing Olympus biopsy valves may have rubber fragments that can detach inside the valve. These fragments could lodge in a patient's airways during a procedure, potentially requiring removal and causing inflammation or reduced oxygen levels.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IIStop using recalled Medline respiratory kits
Medline kits containing Olympus biopsy valves may have rubber fragments that can detach inside the valve. These fragments could enter a patient's airway and require removal, or cause inflammation and breathing problems. Olympus is investigating complaints about this issue.
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