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

4126–4150 of 5038

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-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-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-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-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-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-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-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-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-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-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
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-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
CriticalFDA (Devices)·Z-1951-2015·2015-07-15
Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties
FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.
Product
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1989-2015·2015-07-15
Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides
Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.
Product
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2046-2015·2015-07-15
Biomet Recalls A.L.P.S. Foot Locking Calcaneus Plates Due to Thread Defects
Biomet is recalling 75 A.L.P.S. Foot Locking Calcaneus Plates because thread defects may cause screws to back out or shear, potentially requiring revision surgery.
Product
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1904-2015·2015-07-08
Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Product
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1892-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1873-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1897-2015·2015-07-08
Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2015·2015-07-08
FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues
The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1917-2015·2015-07-08
HeartWare Ventricular Assist System Recalled for Power Switching Issues
HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.
Product
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Category
Medical Device
Distribution
32 states
SevereFDA (Devices)·Z-1888-2015·2015-07-08
Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
Category
Medical Device
Distribution
Distributed nationwide

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4126–4150 of 5038