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

32501–32525 of 40325

ModerateFDA (Devices)·Z-2182-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning 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, 28S, 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2203-2015·2015-07-29
Philips Recalls Head Holders for Ingenuity Core CT Systems
Philips is recalling 79 head holders shipped with Ingenuity Core CT systems because they were not qualified for use on this specific model.
Product
Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
32 states
ModerateFDA (Devices)·Z-2099-2015·2015-07-29
Stryker Neptune 2 Waste Management System Recalled for Diverter Valve Failures
Stryker is recalling the Neptune 2 Waste Management System due to installation failures of the diverter valve assembly during docking.
Product
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish…
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-2170-2015·2015-07-29
FDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Cleaver accessories because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2149-2015·2015-07-29
Gardner Denver MEDI-PUMP Aspirator Recalled for Performance Defects
Gardner Denver Thomas Inc. is recalling 160 MEDI-PUMP Aspirators because the vacuum pump may not perform to specification.
Product
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2165-2015·2015-07-29
Fiber Stripper Recalled for Cleaning and Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.
Product
Fiber Stripper, 200¿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
ModerateFDA (Devices)·Z-2150-2015·2015-07-29
Gardner Denver MEDI-PUMP Aspirator Recalled for Performance Defects
Gardner Denver Thomas Inc is recalling 370 units of the MEDI-PUMP Aspirator, Model 1242, because the vacuum pump may not perform to specification.
Product
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2147-2015·2015-07-29
CooperSurgical Recalls Infant Heel Warmers for Lack of FDA Clearance
CooperSurgical is recalling infant heel warmers sold under CooperSurgical and Fisher brands because they were marketed without FDA 510(k) clearance.
Product
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2124-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 63 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.
Product
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2168-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 550¿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
ModerateFDA (Devices)·Z-2155-2015·2015-07-29
Cochlear Nucleus Sterile Silicone Template Recalled for Expiration
Cochlear Americas is recalling 26 units of Nucleus Sterile Silicone Templates because expired product was distributed to specific US states.
Product
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2104-2015·2015-07-29
Allergan Recalls Natrelle Tissue Expanders for Expired Shelf Life
Allergan is recalling Natrelle CUI Series Tissue Expanders because the shipped products were beyond their shelf life. The recall involves 23 units total, with 16 distributed in the US.
Product
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2180-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning 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, 44S, 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2158-2015·2015-07-29
FDA Recalls Sureflex 273 Lithotripsy Fibers Due to Cleaning Validation Issues
American Medical Systems is recalling Sureflex 273 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 273 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
ModerateFDA (Devices)·Z-2164-2015·2015-07-29
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
Fiber Stripper, 150¿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
ModerateFDA (Devices)·Z-2130-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
Product
Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2159-2015·2015-07-29
FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 365 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
ModerateFDA (Devices)·Z-2185-2015·2015-07-29
FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Stripper, 0.4mm Disposable EndoStat Fiber, 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2125-2015·2015-07-29
Perkinelmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
Product
WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2186-2015·2015-07-29
FDA Recalls American Medical Systems Fiber Strippers for Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.
Product
Stripper, 0.3mm Disposable EndoStat Fiber, 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…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2201-2015·2015-07-29
Myoscience iovera Smart Tip Recalled for Incorrect Expiration Date Labeling
Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.
Product
iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2192-2015·2015-07-29
Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance
Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.
Product
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
Category
Medical Device
Distribution
1 state
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

How to read this listing

Filters

32501–32525 of 40325