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

4626–4650 of 39824

HighFDA (Devices)·Z-1067-2025·2025-02-05
Implantable VNS Therapy Generators May Stop Delivering Treatment
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
Product
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1049-2025·2025-02-05
Medline arterial line catheter packs recalled for missing heparin coating
Medline Industries recalls certain Sterile Infusion Catheters labeled as having antimicrobial heparin coating but lacking this coating. Affected units were either distributed directly or incorporated into medical convenience kits.
Product
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1056-2025·2025-02-05
Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Product
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2025·2025-02-05
HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2025·2025-02-05
Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2025·2025-02-05
X-Ray System Recalled for Potential Excessive Radiation Dose in First Image
Siemens ARTIS One X-ray systems may deliver higher radiation doses during first imaging after patient registration due to copper prefiltration malfunction occurring in very rare situations.
Product
ARTIS One Angiographic X-Ray System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1041-2025·2025-02-05
Medline procedure kits recalled for surgical masks failing sterilization tests
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Product
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2025·2025-02-05
AXIOS Stent Delivery System Outer Sheath Detachment Recall (47 Units)
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2025·2025-02-05
Medtronic Percutaneous Reference Pins May Not Fit Properly
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.
Product
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2025·2025-02-05
Knee Implant Component Recalled for Incorrect Metal Post Assembly
Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1062-2025·2025-02-05
Karl Storz Ureteroscope Model 27001K Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
Product
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2025·2025-02-05
Medical stent delivery system outer sheath component detachment prevents proper expansion
The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2025·2025-02-05
Karl Storz Pediatric Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2025·2025-02-05
AXIOS Stent and Delivery System Recalled for Improper Expansion Risk
The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Product
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2025·2025-02-05
Infusion catheters recalled for missing antimicrobial heparin coating
Medline's CENTURION infusion catheters in certain lots lack the antimicrobial heparin coating they are labeled as having. The mislabeled catheters were distributed to healthcare facilities in eight states.
Product
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1042-2025·2025-02-05
Medline procedure kits recalled for surgical mask bioburden contamination risk
Medline procedure kits containing surgical masks are recalled nationwide because included masks failed to meet bioburden testing standards, creating potential infection risk during medical procedures.
Product
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1024-2025·2025-02-05
AXIOS Stent Delivery System Outer Sheath May Detach During Deployment
Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and requiring device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1063-2025·2025-02-05
Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.
Product
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0960-2025·2025-01-29
VDR4 Phasitron Breathing Circuit Recalled for Potential Ventilation Reduction
Percussionaire Corporation is recalling VDR4 Phasitron breathing circuit models due to a venturi component that may stick and reduce ventilation. This Class I recall affects over 4,700 units worldwide.
Product
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2025·2025-01-29
Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach
Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2025·2025-01-29
Randox Lipoprotein (a) assay distributed without required FDA clearance
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1004-2025·2025-01-29
BD PCR Cartridges for MAX System signal drift in select lots
Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.
Product
BD PCR Cartridges used with MAX System. Model Number: 437519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2025·2025-01-29
Wolf-Pak Dressing Change Kits Recalled Due to Package Defects
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2025·2025-01-29
Microvention Headway Microcatheter Recall Due to Incomplete Packaging Seal
Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.
Product
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0768-2025·2025-01-29
Bodor P and C series laser cutting machines recalled for non-compliance
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
Product
Bodor P and C series laser cutting machines
Category
Medical Device
Distribution
Distributed nationwide

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4626–4650 of 39824