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

3526–3550 of 27346

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
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
HighFDA (Devices)·Z-0744-2025·2025-01-01
TEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern
Limacorporate is recalling TEMA Elbow System prostheses due to potential differences in mechanical behavior between implanted devices and surgical revision tools. Approximately 87 devices distributed in Florida and Texas are affected.
Product
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0735-2025·2025-01-01
Blood analyzer system recalled for patient name assignment software error
Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); 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-0740-2025·2025-01-01
Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect
Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0755-2025·2025-01-01
Medline Surgical Scissors Recalled for Sterility Seal Defect
Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.
Product
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2025·2025-01-01
Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.
Product
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0718-2025·2025-01-01
Surgical patties and strips recalled due to endotoxin contamination
Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.
Product
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2025·2025-01-01
Sterile Kelly Hemostat Recalled Due to Weak Seals
Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.
Product
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0759-2025·2025-01-01
Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk
Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.
Product
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0743-2025·2025-01-01
3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
3M is recalling Clarity Precision Grip Attachments due to a design defect that may prevent proper fitting with digital treatment plans. The recall affects 171 orders distributed in the US, Canada, Australia, and New Zealand.
Product
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2025·2025-01-01
EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays
Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.
Product
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline recalls surgical patties and strips from specific kit lots due to higher-than-expected endotoxin levels. The 318 kits were distributed in the United States and Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2025·2025-01-01
Medline surgical procedure kits recalled due to endotoxin contamination
Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2025·2025-01-01
Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.
Product
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2025·2025-01-01
O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements
O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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

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3526–3550 of 27346