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

4176–4200 of 5111

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-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-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
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
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-2113-2015·2015-07-29
FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves
The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain splits or holes that compromise sterility.
Product
Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2111-2015·2015-07-29
FDA Recalls Sterile Surgical Kits with Compromised Gloves
The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.
Product
ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2136-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitat
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2196-2015·2015-07-29
Philips GEMINI TF 64 Slice CT/PET System Software Defect Recall
Philips is recalling 22 GEMINI TF 64 Slice CT/PET systems due to software defects that may cause incorrect tissue irradiation.
Product
GEMINI TF 64 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-2116-2015·2015-07-29
FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves
The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.
Product
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Category
Medical Device
Distribution
Distributed nationwide
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-2197-2015·2015-07-29
Philips GEMINI TF Ready CT/PET System Software Defect Recall
Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.
Product
GEMINI TF Ready 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-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-2198-2015·2015-07-29
Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects
Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.
Product
GEMINI TF Base 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-2161-2015·2015-07-29
FDA Recalls Sureflex 910 Lithotripsy Fibers Due to Cleaning Validation Issues
American Medical Systems is recalling 16,710 Sureflex 910 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 910 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-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-2175-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 12S, Autoclavable; 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, correspond
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
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-2107-2015·2015-07-29
FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves
The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.
Product
Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2063-2015·2015-07-22
Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size
Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.
Product
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-2060-2015·2015-07-22
Zimmer Recalls ZNN Antegrade Femoral Nail Due to Potential Denting
Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.
Product
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2085-2015·2015-07-22
ViewRay Patient Handling System Software Recalled for Unexpected Movement
ViewRay is recalling three units of Patient Handling System software due to a report of the couch moving unexpectedly into the bore after a reboot.
Product
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Category
Medical Device
Distribution
Distributed nationwide

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4176–4200 of 5111