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.

Agency

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226–250 of 778

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-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-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-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-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-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-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-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
SevereFDA (Food)·H-0781-2026·2026-05-20
Kroger Homestyle Cheese and Garlic Croutons Recalled for Salmonella Risk
Kroger Homestyle Cheese and Garlic Croutons are being recalled due to possible Salmonella contamination in the non-fat milk powder used to manufacture the product. The supplier of the milk powder issued a recall, prompting this product recall.
Product
Kroger HOMESTYLE Cheese AND Garlic CROUTONS NET WT 5 OZ (141g) UPC 0 11110 81353 4 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
Category
Food
Distribution
3 states
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-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-2178-2026·2026-05-20
BARD Dynamic XT Deca Steerable electrophysiology catheter Class II recall
Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable electrophysiology catheter due to incomplete seals on the sterile product.
Product
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
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-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-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
0 states
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-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 (Drugs)·D-0525-2026·2026-05-20
Oasis Tears PF Lubricant Eye Drops Recalled for Sterility Assurance
Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.
Product
OASIS TEARS PF — OASIS TEARS PF (GLYCERIN)
Category
Drug
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-2159-2026·2026-05-20
NextStep Hemodialysis Catheters with Defective Sheath Introducer
Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.
Product
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-1523
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
HighFDA (Devices)·Z-2182-2026·2026-05-20
BARD EP XT Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.
Product
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2026·2026-05-20
Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts
Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring iOS app due to a software defect that delays glucose value notifications and alerts, risking missed detection of dangerous blood sugar events.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0771-2026·2026-05-20
Dakota Honey Company Spreadable Spun Honey Jalapeno Foreign Objects
Dakota Honey Company is recalling Spreadable Spun Honey in Jalapeno flavor due to the potential presence of stainless steel dust, flakes, or plastic shreds. The product was distributed to retail locations in Florida, Georgia, and South Dakota, as well as nationwide via internet sales.
Product
Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41982 1. 2. Net Wt 12 oz (340g) UPC 8 60010-57965 7.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0780-2026·2026-05-20
...And Kimchi branded kimchi recalled for undeclared fish allergen
...And Kimchi branded kimchi is being recalled due to undeclared fish allergen. The product was distributed in California, Texas, and Georgia.
Product
...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409 30oz UPC- 8541200411
Category
Food
Distribution
0 states

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