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

4101–4125 of 5038

SevereFDA (Devices)·Z-2451-2015·2015-09-02
Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections
Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.
Product
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2372-2015·2015-08-26
Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies
Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.
Product
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2367-2015·2015-08-26
Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes
Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.
Product
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring br
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2371-2015·2015-08-26
Elite Biomedical Recalls Alaris Medley LVP Frame Membranes
Elite Biomedical Solutions LLC is recalling 609 Alaris Medley LVP Frame Membranes because the defect could allow fluid intrusion, potentially leading to injury or death.
Product
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2437-2015·2015-08-26
Siemens Intevo Series Imaging Systems Recalled for Overheating Risk
Siemens Medical Solutions USA is recalling 185 Intevo Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.
Product
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-2433-2015·2015-08-26
Medline Electrical Surgical Clippers Recalled for Overheating Charging Base
Medline is recalling 7,602 electrical surgical clippers because the charging base can overheat and smoke. The units were distributed in the U.S. and eight other countries.
Product
Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2399-2015·2015-08-26
Winco Designer Care Cliner Recalled for Non-Fire Retardant Foam
Winco Mfg. is recalling Designer Care Cliner chairs because the foam used was not fire retardant as required.
Product
Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2369-2015·2015-08-26
Teleflex Sheridan SHER-I Bronch Accessory Pack Recalled for Connector Defect
Teleflex Medical is recalling Sheridan SHER-I Bronch Accessory Packs because the double swivel connector may crack or separate on the endobronchial tube.
Product
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2358-2015·2015-08-19
Invacare Pronto Air Power Wheelchair Recall for Battery Overheating Risk
Invacare is recalling 1,057 Pronto Air power wheelchairs because the batteries may overheat during charging, posing risks of chemical burns and property damage.
Product
Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2373-2015·2015-08-19
Fresenius Medical Care Recalls Naturalyte Liquid Bicarbonate Concentrate
Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate due to potential bacterial contamination. The recall covers 2,264,028 units distributed nationwide.
Product
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2325-2015·2015-08-12
Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect
Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.
Product
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2319-2015·2015-08-12
Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation
Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing loss of function or complications.
Product
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2326-2015·2015-08-12
Aesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect
Aesculap is recalling 10 S4C Occiput Torque Wrenches because improper reassembly after reprocessing caused a screw to break during implantation.
Product
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2324-2015·2015-08-12
Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect
Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.
Product
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2318-2015·2015-08-12
Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters
Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.
Product
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2209-2015·2015-08-05
Skeletal Kinetics Recalls InjectionPlasty 1.0 Bone Void Filler Kits
Skeletal Kinetics is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler due to reports of venous uptake, DVT, and pulmonary embolism in implanted patients.
Product
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2271-2015·2015-08-05
Draeger Fabius MRI Anesthesia Machine Recalled for Magnetic Field Attraction
Draeger Medical is recalling 373 Fabius MRI anesthesia machines because their parts can be loosened by the magnetic field of MRI equipment.
Product
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2069-2015·2015-07-29
Western OxyTOTE Portable Oxygen System Regulators Recalled for Ignition Risk
Western / Scott Fetzer Company is recalling OxyTOTE Portable Oxygen System regulators due to a risk of ignition and rupture of the oxygen cylinder.
Product
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply
Category
Medical Device
Distribution
47 states
SevereFDA (Devices)·Z-2174-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2138-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall for Balseal Disassociation Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil may detach and be left in patients during surgery.
Product
ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-2156-2015·2015-07-29
FDA Recalls Sureflex 150 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2110-2015·2015-07-29
Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.
Product
Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2194-2015·2015-07-29
Philips Gemini LXL CT/PET Systems Recalled for Software Defects
Philips is recalling two Gemini LXL CT/PET systems due to software defects that may cause incorrect radiation delivery to patients.
Product
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2195-2015·2015-07-29
Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects
Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.
Product
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2137-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE FB PS Articulation Surface instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
Category
Medical Device
Distribution
51 states

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4101–4125 of 5038