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 390

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-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-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-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-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-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-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-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-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
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-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-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-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-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-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
ModerateFDA (Devices)·Z-2228-2026·2026-05-27
Philips Allura X-ray Systems Deaeration Hose Degradation Recall
Deaeration hoses in Philips Allura X-ray tube cooling units may degrade and leak oil, reducing cooling performance. Affected units were manufactured between February 2016 and May 2020.
Product
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 72
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2213-2026·2026-05-27
OneLIF Interbody Cage Inserter Attachment Failure Recall
Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.
Product
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2226-2026·2026-05-27
Silastic Brand Foley Catheters recalled due to surface stain
C.R. Bard Inc is recalling Silastic Brand Foley Catheters because of stain present on the surface of affected units. The recall affects 106,160 catheters distributed across the United States and Canada.
Product
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Category
Medical Device
Distribution
44 states
ModerateFDA (Devices)·Z-2222-2026·2026-05-27
Medtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
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-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-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-2140-2026·2026-05-20
Namic Angiographic Manifold recalled for particulate contamination
Medline Industries is recalling the Namic Angiographic Manifold (Product Number 64038402) because particulate matter has been found in the fluid path. This medical device is used in cardiopulmonary bypass procedures.
Product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Category
Medical Device
Distribution
Distributed nationwide

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