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

23201–23225 of 27699

HighFDA (Devices)·Z-2166-2015·2015-07-29
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 medical devices.
Product
Fiber Stripper, 273¿m, 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, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2015·2015-07-29
Argon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles
Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.
Product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2118-2015·2015-07-29
FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise
FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.
Product
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY…
Category
Medical Device
Distribution
Distributed nationwide
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-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-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
SevereFDA (Devices)·Z-2082-2015·2015-07-22
FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect
Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.
Product
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2015·2015-07-22
Breas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction
Breas Medical AB is recalling 846 Vivo 50 Home Care Ventilators because a keypad malfunction can cause the device to stop treatment without an alarm.
Product
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2064-2015·2015-07-22
Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk
Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.
Product
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2077-2015·2015-07-22
Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA is recalling 21 Sorin Stockert Heater-Cooler 3T units due to the potential for organism colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.
Product
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2081-2015·2015-07-22
Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA is recalling 131 Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.
Product
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2015·2015-07-22
Biomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error
Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.
Product
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2083-2015·2015-07-22
Maquet Recalls FLOW-i Anesthesia System Modules Due to Suction Failure
Maquet is recalling 104 FLOW-i Anesthesia System Auxiliary O2 and Suction Modules because the suction function may not activate or be controlled by the switch.
Product
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2015·2015-07-22
Eizo RadiForce RX850 Medical Monitors Recalled for Display Abnormalities
Eizo is recalling RadiForce RX850 medical monitors because they may display images abnormally when connected to specific graphics boards using DisplayPort.
Product
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2058-2015·2015-07-22
Biomet Recalls 50 A.L.P.S. Cortical Locking Screws Due to Packaging Defect
Biomet, Inc. is recalling 50 A.L.P.S. 3.5mm x 60 mm Cortical Locking Screws because the sterile packaging was not sealed, posing a risk of infection.
Product
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2079-2015·2015-07-22
Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA is recalling 28 Sorin Stockert Heater-Cooler 3T devices due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.
Product
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2076-2015·2015-07-22
Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA, Inc. is recalling 2,837 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.
Product
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2062-2015·2015-07-22
Stryker Woundcare Replacement Kits Recalled for Potential Sterility Breach
Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.
Product
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2015·2015-07-22
Northern Digital recalls disposable reflective marker spheres for surgical tracking
Northern Digital Inc. is recalling 32,400 disposable reflective marker spheres used in Brainlab IGS systems due to inadequate adhesive curing that may cause the spheres to separate.
Product
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2015·2015-07-22
Exactech Spine Set Screw Recalled for Incorrect Thread Form
Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.
Product
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2073-2015·2015-07-22
Etac Supporter toilet armrest recalled due to loose fasteners
Etac Supply Center Ab is recalling 25 units of Supporter toilet armrests because fasteners may come loose, causing the product to become unsteady.
Product
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2078-2015·2015-07-22
Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization
Sorin Group USA is recalling 283 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection is not performed.
Product
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2095-2015·2015-07-22
Alere i Influenza A & B Kit Recalled for False Negative Risk
Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.
Product
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2084-2015·2015-07-22
NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect
Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.
Product
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2015·2015-07-22
Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk
Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.
Product
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary…
Category
Medical Device
Distribution
Distributed nationwide

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23201–23225 of 27699