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

25676–25700 of 40233

SevereFDA (Devices)·Z-3142-2017·2017-09-27
Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage
Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.
Product
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of…
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-3137-2017·2017-09-27
Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties
Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed worldwide.
Product
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3135-2017·2017-09-27
Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error
Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.
Product
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3136-2017·2017-09-27
Medtronic Euphora Balloon Catheter Recalled for Stylette Removal Difficulties
Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 69,081 units distributed in the US and worldwide.
Product
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3134-2017·2017-09-27
BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures
BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing testing failures.
Product
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-3138-2017·2017-09-27
Kamiya Biomedical Recalls K-Assay Multi-Analyte Calibrator Due to Incorrect Values
Kamiya Biomedical is recalling specific lots of the K-Assay Multi-Analyte Calibrator because the Alpha-1 Antitrypsin (AlAT) values listed in the package insert were incorrect.
Product
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4…
Category
Medical Device
Distribution
15 states
SevereFDA (Devices)·Z-3109-2017·2017-09-20
Leonhard Lang Skintact Defibrillation Electrodes Recalled for Connection Failure
Leonhard Lang is recalling Skintact defibrillation electrodes that may fail to connect with ZOLL AED PLUS devices, potentially delaying life-saving treatment.
Product
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-3117-2017·2017-09-20
Zimmer Biomet Recalls ROSA Surgical Device Foot Switches
Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.
Product
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3133-2017·2017-09-20
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.
Product
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3127-2017·2017-09-20
Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core
Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.
Product
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3130-2017·2017-09-20
Mako Surgical Recalls Robotic Knee System Due to Software Display Error
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.
Product
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3111-2017·2017-09-20
Toshiba Medical Radrex-i Digital Radiography X-ray System Recalled for Software Error
Toshiba American Medical Systems is recalling 140 Radrex-i digital radiography systems because a software error causes image loss and requires a system reboot.
Product
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3120-2017·2017-09-20
Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of required temperature limits.
Product
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3121-2017·2017-09-20
Leica Biosystems Recalls Glypican-3 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling three units of Glypican-3 (1G12 Mab) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
Product
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3115-2017·2017-09-20
Implant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect
Implant Direct Sybron is recalling 84 Guided Surgery Handle Kits because the 2.3mm drill guide inserts have a smaller inside diameter than specifications require.
Product
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3118-2017·2017-09-20
Beckman Coulter Recalls Sekisui Acetaminophen Reagent Due to Carryover
Beckman Coulter is recalling 320 units of Sekisui Acetaminophen reagent because carryover from ACTH reagent may cause falsely elevated Lipase results on the AU 680 analyzer.
Product
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3131-2017·2017-09-20
Mako Surgical Recalls Robotic Arm Interactive Orthopedic System Software
Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.
Product
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3126-2017·2017-09-20
Leica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling 37 units of SOX-10 (Polyclonal) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
Product
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3124-2017·2017-09-20
Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
Product
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3122-2017·2017-09-20
Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.
Product
Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3116-2017·2017-09-20
Becton Dickinson Recalls SafetyGlide Needles Due to Foreign Matter
Becton Dickinson is recalling 1,249,200 units of BD SafetyGlide needles because they contain loose polypropylene foreign matter above release specifications.
Product
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings…
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-3119-2017·2017-09-20
bioMerieux Recalls eMAG System Due to Manufacturing Anomalies
bioMerieux, Inc. is recalling 15 eMAG System units in the US and 11 countries due to anomalies identified during manufacturing controls.
Product
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3125-2017·2017-09-20
Leica Biosystems Recalls PAX8 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling five units of PAX8 antibody because a transit delay may have caused the product to be stored outside required temperature limits.
Product
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3129-2017·2017-09-20
Fujifilm Endoscope Corrective Action Following FDA Inspection
Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.
Product
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3123-2017·2017-09-20
Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.
Product
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the…
Category
Medical Device
Distribution
Distributed nationwide

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