Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 501 - 525 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2179-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2190-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip. Out-of-specification endotoxin result that did not meet the acceptance criteria.	FDA Z-2173-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.	FDA Z-2152-2026	Medical Device	High	May 20, 2026 Recall: Mar 26, 2026	Details
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS. Complaints have been received of systems developing loose, missing, or broken internal bolts over time.	FDA Z-2168-2026	Medical Device	High	May 20, 2026 Recall: Apr 8, 2026	Details
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No Due to broken connector which may result in a temporary interruption of prescribed cold therapy.	FDA Z-2135-2026	Medical Device	High	May 20, 2026 Recall: Mar 19, 2026	Details
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2186-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Medline has identified the presence of particulate within the fluid path of the Manifolds.	FDA Z-2139-2026	Medical Device	High	May 20, 2026 Recall: Mar 24, 2026	Details
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.	FDA Z-2154-2026	Medical Device	High	May 20, 2026 Recall: Mar 26, 2026	Details
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.	FDA Z-2165-2026	Medical Device	High	May 20, 2026 Recall: Apr 14, 2026	Details
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2180-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2189-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.	FDA Z-2172-2026	Medical Device	High	May 20, 2026 Recall: Mar 27, 2026	Details
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2199-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282). Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.	FDA Z-2170-2026	Medical Device	High	May 20, 2026 Recall: Mar 31, 2026	Details
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60132238; 10. MTS,3,PORT,KIT, Medline Kit Number/SKU 60138301; 11. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 601 Medline has identified the presence of particulate within the fluid path of the Manifolds.	FDA Z-2144-2026	Medical Device	High	May 20, 2026 Recall: Mar 24, 2026	Details
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2188-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2194-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. Medline has identified the presence of particulate within the fluid path of the Manifolds.	FDA Z-2145-2026	Medical Device	High	May 20, 2026 Recall: Mar 24, 2026	Details
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2183-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Diowave Laser System, REF: Diowave 250W Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.	FDA Z-2162-2026	Medical Device	High	May 20, 2026 Recall: Jan 9, 2026	Details
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.	FDA Z-2171-2026	Medical Device	High	May 20, 2026 Recall: Apr 1, 2026	Details
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no Due to broken connector which may result in a temporary interruption of prescribed cold therapy.	FDA Z-2134-2026	Medical Device	High	May 20, 2026 Recall: Mar 19, 2026	Details
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER Incomplete seals on sterile product	FDA Z-2185-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.	FDA Z-2158-2026	Medical Device	High	May 20, 2026 Recall: Apr 10, 2026	Details

Showing 501 - 525 of 1,678 product recalls

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Medical Device Recalls Today

Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.

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

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