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

4926–4950 of 39987

HighFDA (Devices)·Z-0783-2025·2025-01-08
Medline Surgical Procedure Kits Recalled for Non-Sterile Components
Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.
Product
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0798-2025·2025-01-08
Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise
Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.
Product
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0774-2025·2025-01-08
SynchroMed II and III Implantable Pumps Recalled for Software Issues
Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.
Product
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0792-2025·2025-01-08
Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination
Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, and Canada.
Product
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0785-2025·2025-01-08
Medline surgical procedure kits recalled for potential endotoxin contamination
Medline is recalling three custom surgical procedure kits due to non-sterile Codman Surgical Patties and Strips that pose a potential endotoxin contamination risk. The affected kits were distributed in the US, Canada, and the UAE.
Product
Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0796-2025·2025-01-08
Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach
Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.
Product
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0770-2025·2025-01-08
Auryon Laser Atherectomy System Recalled for Activation Failure
Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.
Product
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0708-2025·2025-01-01
Cardiac Monitoring Software Failed to Properly Route ECG Events
Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.
Product
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0683-2025·2025-01-01
Blood glucose ketone meter software bug causes erroneous result transmission
Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.
Product
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0681-2025·2025-01-01
Glucose Hospital Meter Software Bug Transmits Inaccurate Results
StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.
Product
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0682-2025·2025-01-01
Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results
Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.
Product
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply May Fail During Use
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
Product
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0760-2025·2025-01-01
RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall
Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.
Product
RUMMELL, Medline Item No. ST006ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0730-2025·2025-01-01
Abbott 20/30 Indeflator devices recalled for potential leak risk
Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.
Product
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0722-2025·2025-01-01
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels in Kits
Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.
Product
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2025·2025-01-01
Galaxy System bronchoscope power supply defect may injure lung tissue
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0749-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.
Product
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0738-2025·2025-01-01
Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error
Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2025·2025-01-01
Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures
Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.
Product
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0745-2025·2025-01-01
BD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall
BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.
Product
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2025·2025-01-01
MISHA Knee System Implants recalled due to fracture risk
Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.
Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0726-2025·2025-01-01
Surgical procedure kits recalled for elevated endotoxin levels
Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0737-2025·2025-01-01
Blood Analysis System Software Malfunction May Assign Incorrect Patient Names
Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2025·2025-01-01
FDA Recalls Medical Spine Component Due to Manufacturing Defects
SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.
Product
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide

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4926–4950 of 39987