Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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1–25 of 247

SevereFDA (Devices)·Z-2218-2026·2026-05-27
Medtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94725), a cardiopulmonary bypass catheter, because the sterile barrier may be breached, potentially allowing contamination. The cannulas were distributed worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2216-2026·2026-05-27
Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94215T) due to a potential sterile barrier breach. The affected product is a cardiopulmonary bypass vascular catheter distributed worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2202-2026·2026-05-27
Swan-Ganz Catheters Models 131F7 Through AIQSGF8 Recalled Nationwide
Becton, Dickinson and Company is recalling multiple models of Swan-Ganz Catheters due to potential leaking or breaking of the proximal injectate lumen hub that could lead to infection, medication loss, or blood loss.
Product
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2209-2026·2026-05-27
Tangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
Tangent Endoscopy is recalling its Tangent Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) due to fractures observed at the distal shaft tip without complete detachment, posing a risk during endoscopic procedures.
Product
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2217-2026·2026-05-27
Medtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula Model 94665 due to potential sterile barrier breach. The product is used in cardiopulmonary bypass procedures worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2204-2026·2026-05-27
Swan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
Becton, Dickinson and Company is recalling Swan-Ganz Pacing Catheter Model D200F7 due to a manufacturing defect that may cause the proximal injectate lumen hub to leak or break, potentially leading to infection, medication loss, or blood loss.
Product
Swan-Ganz Pacing Catheter, Models: D200F7;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2026·2026-05-27
Medtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94913), a cardiopulmonary bypass vascular catheter, due to a potential sterile barrier breach.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2026·2026-05-27
Integris-Allura X-ray systems with degraded deaeration hoses recalled
Philips is recalling Integris-Allura X-ray systems because deaeration hoses in X-ray tube cooling units may degrade, causing oil leakage that reduces cooling performance and triggers a system shutdown to low-dose mode.
Product
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2220-2026·2026-05-27
Medtronic DLP Retrograde Cannula 13FR Model 94913L Recall
Medtronic is recalling certain lots of DLP Retrograde Cannula (Model 94913L), a cardiopulmonary bypass catheter, due to potential sterile barrier breaches. The affected device was distributed worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2215-2026·2026-05-27
Medtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94115T) cardiopulmonary bypass vascular catheters due to potential sterile barrier breach. The affected product has been distributed worldwide.
Product
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2225-2026·2026-05-27
Philips Azurion X-Ray Systems Table Movement Control Defect Recall
Philips Azurion X-ray imaging systems may experience impaired table movement due to mechanical wear in the Float Tabletop control. The control module defect could affect longitudinal and transverse table positioning during medical procedures.
Product
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2227-2026·2026-05-27
Azurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
The deaeration hose in Philips Azurion X-ray tube cooling units may degrade over time and leak oil, affecting cooling performance and automatically triggering low-dose fluoroscopy mode.
Product
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2026·2026-05-27
Medtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, due to potential sterile barrier breach in the product.
Product
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2026·2026-05-27
Oncology Kit With Extension Sets May Leak During Infusion Therapy
ICU Medical is recalling Oncology Kits with extension sets due to potential leaks that could interrupt chemotherapy infusion and expose hazardous substances to patients, caregivers, and pharmacy technicians.
Product
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2203-2026·2026-05-27
Swan-Ganz Jr Catheter models recalled due to lumen hub leakage
Becton, Dickinson and Company is recalling Swan-Ganz Jr Catheters (models SGPT54, SGPT64P, SGPT755P) because the blue proximal injectate lumen hub may leak or break due to manufacturing changes, risking infection, medication loss, and blood loss.
Product
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2026·2026-05-27
Medtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94915), a cardiopulmonary bypass vascular catheter, due to potential sterile barrier breach.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2133-2026·2026-05-20
On-X Mitral Heart Valve Model ONXMC-25/33 Released Without Complete Testing
On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because the valves were distributed before all required testing was complete, preventing confirmation that they meet all release specifications.
Product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2157-2026·2026-05-20
Arrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer
Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.
Product
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-1555
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2148-2026·2026-05-20
Medline Medical Convenience Kits with Namic Manifold Recalled
Medline is recalling 107 medical convenience kits containing Namic Manifold (TAVI) due to particulate found in the fluid path. The kits were distributed nationwide and internationally.
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2145-2026·2026-05-20
Medline Cardiac Catheterization Kits Recalled for Particulate Contamination
Medline Industries is recalling multiple cardiac catheterization kits because particulate contamination has been found within the fluid path of the manifolds used in these kits.
Product
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, Medli
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2146-2026·2026-05-20
Medline Medical Convenience Kits with Namic Manifold Fluid Contamination
Medline Industries is recalling medical convenience kits (HEART CATH PACK-LF, Kit Number DYNJ36478B) due to particulate matter found in the fluid path of the Namic Manifold. Affected kits were distributed in the US and internationally.
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2066-2026·2026-05-20
Medical Angiographic Control Syringes Recalled for Rotating Adapter Risk
Windstone Medical Packaging is recalling Custom Convenience Kits containing Medline Namic Angiographic Control Syringes due to risk that the rotating adapter may unwind during use, potentially causing disconnection and exposure to biohazards, blood loss, infection, or air embolism.
Product
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2158-2026·2026-05-20
Cannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2192-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.
Product
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2144-2026·2026-05-20
Medline Cardiac Catheterization Kits Recalled for Particulate Contamination
Medline Industries is recalling multiple cardiac catheterization kits due to the presence of particulate matter in the fluid path of manifolds. The affected kits were distributed nationwide and internationally.
Product
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/S
Category
Medical Device
Distribution
Distributed nationwide

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