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 the agency’s own highest classification or reported deaths or serious injuries, 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

24901–24925 of 27686

HighFDA (Devices)·Z-2033-2014·2014-07-16
Zimmer M/L Taper Hip Stem Recall Due to Black Residue
Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.
Product
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1923-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1920-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1978-2014·2014-07-09
Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk
Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.
Product
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1985-2014·2014-07-09
Siemens Mobilett XP X-ray System Recalled for Fire Hazard
Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.
Product
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1922-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1989-2014·2014-07-09
GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.
Product
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1948-2014·2014-07-09
Ventlab Manual Resuscitator Bags Recalled Due to Valve Defect
Ventlab LLC is recalling 251,384 manual resuscitator bags because a defective pop-off valve may prevent air delivery during emergency resuscitation.
Product
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1921-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1959-2014·2014-07-09
Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk
Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1924-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1988-2014·2014-07-09
GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.
Product
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1991-2014·2014-07-09
Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.
Product
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1981-2014·2014-07-09
Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner catheter may separate from the hub during use, potentially requiring intervention to prevent injury.
Product
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1931-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1952-2014·2014-07-09
Medical Action Industries Recalls Sterile Suture Sets Due to Seal Defects
Medical Action Industries is recalling sterile suture sets because incomplete seals may compromise sterility. The recall involves 474 cases distributed across 15 states.
Product
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1951-2014·2014-07-09
Medical Action Industries Recalls Sterile Laceration Kits Due to Seal Defects
Medical Action Industries is recalling sterile laceration and suture removal kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1983-2014·2014-07-09
Anspach Pneumatic and Electric Motor Systems Recalled for Sterility Assurance Failures
The Anspach Effort, Inc. is recalling 115,988 pneumatic and electric motor systems because certain attachments failed to meet sterility assurance levels during sterilization.
Product
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1944-2014·2014-07-09
Siemens syngo Lab Data Manager Software Recall for Configuration Errors
Siemens is recalling syngo Lab Data Manager software because configuration errors may cause test results to bypass manual review and release to the Laboratory Information System.
Product
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1961-2014·2014-07-09
Integra Recalls NewPort MIS Rod 2 Due to Potential Misalignment
Integra LifeSciences is recalling 94 units of NewPort MIS Rod 2 because the rods may be offset from specifications, potentially causing misalignment during surgical insertion.
Product
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1979-2014·2014-07-09
Nihon Kohden CNS-6201 Central Nurse Station Software Recall
Nihon Kohden is recalling CNS-6201 Central Nurse Stations with software version 02-26 due to unexpected reboots that interrupt patient data display and alarms.
Product
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1947-2014·2014-07-09
Alcon Anterior Chamber Cannula Recall Due to Incorrect Component
Alcon is recalling CUSTOM-PAKs that contain a sharp tip needle instead of the intended anterior chamber cannula.
Product
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2014·2014-07-09
Medical Action Industries Recalls Max Barrier Kits Due to Seal Defects
Medical Action Industries is recalling Max Barrier Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1955-2014·2014-07-09
Medical Action Industries Recalls Safety Laceration Kits Due to Seal Defects
Medical Action Industries is recalling Safety Laceration Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1963-2014·2014-07-09
Baxter Exactamix Compounder Recall Due to Software Configuration Error
Baxter Healthcare is recalling Exactamix 1200 and 2400 Compounders because a software error may prevent pump tube flushing, risking cross-contamination of IV solutions.
Product
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds…
Category
Medical Device
Distribution
Distributed nationwide

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24901–24925 of 27686