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

25826–25850 of 40357

ModerateFDA (Devices)·Z-3044-2017·2017-09-06
Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.
Product
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3076-2017·2017-09-06
BioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards
BioMérieux is recalling VITEK 2 Compact 30 software and reagent cards because a software update prevents test cards from finalizing results, potentially disrupting laboratory processing.
Product
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3077-2017·2017-09-06
Edwards Lifesciences Recalls Fogarty Adherent Clot Catheters Due to Balloon Size Error
Edwards Lifesciences is recalling specific Fogarty Adherent Clot Catheters because the balloon diameter measures 6mm instead of the intended 10mm.
Product
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0008-2018·2017-09-06
Optovue iVue Recall for Missing 510(k) on Vault Mapping Software
Optovue is recalling 326 iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.
Product
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3092-2017·2017-09-06
Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak
Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.
Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2018·2017-09-06
Optovue iFusion and iVue Recalled for Missing 510(k) Approval
Optovue is recalling 326 iFusion and iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.
Product
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3078-2017·2017-09-06
Certified Safety Mfg Recalls Sterile Burn Sheets for Shredding Risk
Certified Safety Mfg Inc is recalling sterile burn sheets included in first aid kits because they may shred, potentially failing to protect patients from infection.
Product
Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3097-2017·2017-09-06
Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak
Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.
Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3101-2017·2017-09-06
Beckman Coulter UniCel DxH Slidemaker Stainer Recall for Fitting Seal Defect
Beckman Coulter is recalling 310 UniCel DxH Slidemaker Stainer units because a fitting may not completely seal after installation.
Product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3084-2017·2017-09-06
Alere iScreen Dx Urine Drug Screen Card Recalled for Labeling Error
Ameditech Inc is recalling Alere iScreen Dx Urine Drug Screen Cards because the kit box label incorrectly identifies PCP instead of TCA as a drug analyte.
Product
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3047-2017·2017-08-30
Solta Medical Recalls VASER Amplifiers Due to Burn Risk
Solta Medical is recalling four VASER Amplifier units because a service depot repair may have caused inaccurate calibration, posing a burn risk to patients.
Product
VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-3054-2017·2017-08-30
Medtronic AxiEM ENT Suction Devices Recalled for Verification Failure
Medtronic is recalling 60 reusable ENT suction instruments because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3059-2017·2017-08-30
Custom Assemblies Recalls Custom Surgical Kits with Defective BD Needles
Custom Assemblies Inc is recalling 2,155 custom surgical kits because they contain BD SafetyGlide needles with loose polypropylene particulate in the fluid path.
Product
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3066-2017·2017-08-30
Shippert Medical Technologies Recalls Tissu-Trans SFILL 360 Due to Seal Integrity
Shippert Medical Technologies is recalling Tissu-Trans SFILL 360 devices because the seal integrity of the sterile packages cannot be assured.
Product
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3049-2017·2017-08-30
Alcon ORA System Recall for Incorrect IOL Power Measurements
Alcon is recalling 429 ORA Systems with VerifEye+ Carts due to a software error that may cause incorrect intraocular lens power measurements during cataract surgery.
Product
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3061-2017·2017-08-30
Shippert Medical Technologies Recalls Tissu-Trans Filtron 250 Due to Seal Integrity
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 250 because the seal integrity of the sterile packages cannot be assured.
Product
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3052-2017·2017-08-30
Medtronic Curved Suction 70 Recalled for Verification Failure
Medtronic is recalling 149 Curved Suction 70 ENT instruments because they fail required pre-use verification checks.
Product
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3063-2017·2017-08-30
Shippert Medical Technologies Recalls Tissu-Trans Filtron 1000 Due to Seal Integrity
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 1000 because the seal integrity of the sterile packages cannot be assured.
Product
Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3048-2017·2017-08-30
Solta Medical Recalls VASER PRO Amplifiers Due to Burn Risk
Solta Medical is recalling seven VASER PRO Amplifiers because a service depot repair may have caused inaccurate calibration, posing a risk of patient burns.
Product
VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-3064-2017·2017-08-30
FDA Recalls Tissu-Trans Filtron 2000 Due to Sterile Seal Integrity Concerns
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 2000 because the sterile package seal integrity cannot be assured.
Product
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3065-2017·2017-08-30
Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Seal Integrity
Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 devices because the seal integrity of the sterile packages cannot be assured.
Product
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3058-2017·2017-08-30
Medtronic ENT Navigation Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling six kits of ENT suction devices because they fail required pre-use verification checks.
Product
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3069-2017·2017-08-30
Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect
Medtronic is recalling Deep Brain Stimulation lead kits because the depth stop may not secure properly, potentially causing the lead to be placed beyond the intended target.
Product
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead…
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-3051-2017·2017-08-30
Medtronic ENT Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling 277 reusable ENT suction instruments because they fail pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3050-2017·2017-08-30
Alcon ORA System Recall for Incorrect IOL Power Measurements
Alcon is recalling 367 ORA Systems with VerifEye because a software error may cause incorrect intraocular lens power measurements during cataract surgery.
Product
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Category
Medical Device
Distribution
Distributed nationwide

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25826–25850 of 40357