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

3226–3250 of 27375

HighFDA (Devices)·Z-1118-2025·2025-02-12
Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters
Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.
Product
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a he
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1076-2025·2025-02-12
Philips Allura CV20 patient tables risk finger entrapment during repositioning
The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.
Product
Allura CV20 System Code: 722031
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0991-2025·2025-02-05
Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect
Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.
Product
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2025·2025-02-05
Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect
Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.
Product
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Category
Medical Device
Distribution
Distributed nationwide
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-1032-2025·2025-02-05
Outer Sheath Detachment in HOT AXIOS Stent Delivery System
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2025·2025-02-05
HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Product
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
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-1035-2025·2025-02-05
Stent system outer sheath may detach, preventing proper expansion
Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1050-2025·2025-02-05
BD Pyxis MedStation Door Latch Assembly Failures in Automated Dispensing Cabinets
The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.
Product
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized he
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-1026-2025·2025-02-05
AXIOS stent delivery system outer sheath detachment prevents proper expansion
Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2025·2025-02-05
AXIOS Stent Delivery System Outer Sheath May Detach During Use
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1054-2025·2025-02-05
Karl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
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-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-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-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-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-1061-2025·2025-02-05
Karl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
Product
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
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
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-1066-2025·2025-02-05
Infinity Central Station speakers may fail to produce critical patient alarms
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Product
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2025·2025-02-05
Karl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2025·2025-02-05
Boston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2025·2025-02-05
CyberKnife Treatment System: Internal Snap Ring Detachment Risk
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
Product
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions,
Category
Medical Device
Distribution
Distributed nationwide

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3226–3250 of 27375