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

201–225 of 5027

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-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-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-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-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-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-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-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-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
CriticalFDA (Devices)·Z-1934-2026·2026-05-13
Cook Centimeter Sizing Catheter recall due to marker band cracking
Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.
Product
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1935-2026·2026-05-13
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Product
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2007-2026·2026-05-13
Medical Action Industries Pack Cath BHH Catheter Kit Recall
Medical Action Industries is recalling Pack Cath BHH catheter kits because the rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1942-2026·2026-05-13
VOCSN V+Pro Ventilator System Respiratory Device Safety Recall
Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.
Product
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2118-2026·2026-05-13
Medline Convenience Kits recalled for potential sterility assurance defects
Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.
Product
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTAN
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1975-2026·2026-05-13
Halyard HEART CATH SELF REGIONAL kit syringe adapter disconnection hazard
AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2114-2026·2026-05-13
Medline Surgical Convenience Kits recalled for sterilization calibration defect
Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.
Product
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2108-2026·2026-05-13
Medline Labor and Delivery Kits Recalled for Sterilization Calibration Issues
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1978-2026·2026-05-13
Halyard SAMMC Angiography Kit syringe rotating adapter unwinding recall
Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.
Product
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1981-2026·2026-05-13
Coronary angio packs recalled over Medline syringe rotating adaptor defect
Coronary angio convenience kits are being recalled because they contain Medline Namic syringes whose rotating adaptor may unwind, risking disconnection from the manifold.
Product
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2097-2026·2026-05-13
Medline Convenience Kits recalled for potential sterilization issues
Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.
Product
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1971-2026·2026-05-13
Halyard CARDIAC CATH PACK SAN23CARDQ Kit Syringe Adapter Risk
AVID Medical is recalling Halyard CARDIAC CATH PACK SAN23CARDQ kits (Model DRCC36) due to a Medline syringe rotating adapter that may unwind during use, potentially causing loose or full disconnection between the syringe and manifold.
Product
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1855-2026·2026-05-13
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Category
Medical Device
Distribution
49 states
SevereFDA (Devices)·Z-1977-2026·2026-05-13
Halyard PERC TRAY Kit Syringe Adaptor Connection Risk Recall
The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2064-2026·2026-05-13
Endoscopy Pump Tubing/Cap Set water aspiration risk recall
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.
Product
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2091-2026·2026-05-13
Medline Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
Product
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

201–225 of 5027