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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

901–925 of 39948

SevereFDA (Devices)·Z-2047-2026·2026-05-20
Omnicell i.v.Station label stock rolls for syringe preparation
Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.
Product
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automat
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2138-2026·2026-05-20
Namic Angiographic Manifold Recalled for Particulate Contamination
Medline Industries is recalling approximately 7,075 units of the Namic Angiographic Manifold (SKU 64038200) due to particulate found in the fluid path. The manifold is used in cardiopulmonary bypass procedures and is distributed across the US and internationally.
Product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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-2186-2026·2026-05-20
Reprocessed Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.
Product
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2200-2026·2026-05-20
LVIS Intraluminal Support Device Stent Recalled Dimensional Nonconformance
MICROVENTION INC. is recalling LVIS Intraluminal Support Devices due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling, creating risk of vessel injury, thrombosis, or neurological events.
Product
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
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-2167-2026·2026-05-20
Hologic Selenia Dimensions Mammography Systems Loose Internal Bolts
Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.
Product
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-0
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-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-2139-2026·2026-05-20
Namic Angiographic Manifold recalls due to particulate contamination
Medline Industries is recalling Namic Angiographic Manifolds because particulate has been found in the fluid path of the devices. The affected units were distributed nationwide in the U.S. and internationally.
Product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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
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-2156-2026·2026-05-20
Arrow Edge hemodialysis kits contain a sheath introducer that may not split
Arrow Edge Hemodialysis Catheterization Products are being recalled because they include a 16F splittable sheath introducer, subject to a supplier recall, that may not split as intended.
Product
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
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
SevereFDA (Devices)·Z-2142-2026·2026-05-20
Namic Preceptor Manifold extravascular blood pressure transducer
Medline is recalling the Namic Preceptor Manifold due to particulate matter found in the fluid path. The recall affects 760 units distributed in the US and eight other countries.
Product
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2141-2026·2026-05-20
Namic Preceptor Manifold blood pressure transducers recalled for particulate contamination
Medline Industries is recalling Namic Preceptor Manifold extravascular blood pressure transducers due to the presence of particulate matter within the fluid path. The recall affects 6,390 units distributed nationwide in the US and internationally.
Product
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
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-2196-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2143-2026·2026-05-20
Medline Medical Convenience Kits with Namic Manifold recalled
Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models distributed nationwide and internationally.
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2147-2026·2026-05-20
Medline medical convenience kits recalled for particulate contamination
Medline Industries is recalling cardiac medical convenience kits containing Namic Manifolds due to the presence of particulate matter within the fluid path. The affected kits were distributed nationwide and internationally.
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2194-2026·2026-05-20
Daig Livewire Steerable Reprocessed Electrophysiology Catheters Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging. The defect may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2026·2026-05-20
Medtronic SynchroMed Flex Infusion Programmer Software Application
Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.
Product
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2184-2026·2026-05-20
Reprocessed electrophysiology catheters recalled over incomplete sterile seals
The CS Uni-Directional with Auto ID reprocessed electrophysiology catheter is being recalled because of incomplete seals on the sterile product. 449 units are affected.
Product
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.
Product
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2185-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Product
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

901–925 of 39948