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

22601–22625 of 40175

HighFDA (Devices)·Z-2959-2018·2018-09-12
Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect
Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.
Product
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2992-2018·2018-09-12
Hitachi VidiStar PACS Software Recalled for Potential Image Mix-Up
Hitachi is recalling VidiStar PACS software versions 3.10.5 and 3.10.6 because a defect may cause images from multiple patients to appear in a single study.
Product
VidiStar(TM) PACS & DICOM Viewer Software system
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2989-2018·2018-09-12
GE Vivid 7 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 Vivid 7 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2978-2018·2018-09-12
Medline Recalls Non-Sterile Laparoscopy CDS Kits Due to Sterilization Error
Medline Industries is recalling 15 kits of Laparoscopy CDS because a non-sterile anti-fog component was not exposed to the sterilization process.
Product
Laparoscopy CDS
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2988-2018·2018-09-12
GE Vivid E95 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 Vivid E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2987-2018·2018-09-12
GE Vivid E90 Ultrasound System Recalled for Electrical Shock Risk
GE Medical Systems is recalling Vivid E90 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of shock.
Product
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2984-2018·2018-09-12
GE LOGIQ 9 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 LOGIQ 9 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2976-2018·2018-09-12
Medline Recalls Art-Line Surgery Packs Due to Non-Sterile Component
Medline is recalling 3,000 Art-Line Surgery Packs because a non-sterile CHG disk was attached to the outside of the sterile packaging, posing a potential infection risk.
Product
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2986-2018·2018-09-12
GE Vivid E80 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling Vivid E80, E90, and E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.
Product
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2983-2018·2018-09-12
GE LOGIQ E9 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 LOGIQ E9 ultrasound systems because the power cord side may break, exposing electrical conductors and creating a risk of electric shock.
Product
GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2985-2018·2018-09-12
GE Vivid E9 Ultrasound System Recalled for Power Cord Shock Risk
GE Medical Systems is recalling 12,426 Vivid E9 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of electric shock.
Product
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2979-2018·2018-09-12
Medline Recalls Cardiac Insulation Pads Due to Sterilization Error
Medline Industries is recalling 77 kits of Cardiac Insulation Pads because a non-sterile component was not properly sterilized.
Product
Cardiac Insulation Pad, OPEN HEART CDS
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2981-2018·2018-09-12
Alden Optical Recalls Zenlens Toric Contact Lenses Due to Labeling Errors
Alden Optical is recalling 36 vials of Zenlens Toric-Gas Permeable Contact Lenses because the vials contained incorrect lenses for the prescriptions labeled on them.
Product
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve +…
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2975-2018·2018-09-12
Quasar Pure Rayz Light Therapy System Recalled for Uncleared Claims
Quasar Bio-Tech is recalling 6,783 Pure Rayz Light Therapy Systems because the packaging and manuals make claims about collagen and elastin production that were not cleared by the FDA.
Product
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2965-2018·2018-09-12
Zimmer Biomet Recalls 2.5mm Orthopedic Pegs Due to Packaging Error
Zimmer Biomet is recalling 2.5mm orthopedic pegs because a larger 22mm peg was found in the package. The error affects 25 units distributed to Japan and the Netherlands.
Product
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2967-2018·2018-09-12
Encore Medical Recalls Foundation Modular Femoral Stem for Lack of Clearance
Encore Medical is recalling 12 units of the Foundation Modular Femoral Stem because the device lacks FDA clearance.
Product
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2969-2018·2018-09-12
Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date
Inspire Medical Systems is recalling 93 Inspire II Implantable Pulse Generators because the device registration labels contain an incorrect use-by date.
Product
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2973-2018·2018-09-12
Quasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System
Quasar Bio-Tech is recalling the Baby Quasar Plus Light Therapy System because it lacks FDA clearance for specific collagen and elastin claims.
Product
Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2974-2018·2018-09-12
Quasar MD Plus Light Therapy System Recalled for Uncleared Claims
Quasar Bio-Tech, Inc. is recalling the Quasar MD Plus Light Therapy System because the packaging and user manuals contain claims for collagen and elastin production that were not cleared by the FDA.
Product
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2964-2018·2018-09-12
Canon Medical Wireless Flat Panel Detector Recall for Image Transmission Failure
Canon Medical System is recalling 43 wireless flat panel detectors because they may fail to transmit images, requiring repeated attempts to acquire data.
Product
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2982-2018·2018-09-12
Alden Optical Recalls Zen RC Toric Contact Lenses with Incorrect Contents
Alden Optical is recalling Zen RC Toric contact lenses because vials labeled for specific prescriptions contained incorrect lenses.
Product
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the…
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2966-2018·2018-09-12
Exactech Recalls Tibial Alignment Guides Due to Incorrect GTIN Labeling
Exactech is recalling 7 Tibial Alignment Guides because the Global Trade Item Number (GTIN) printed on the devices is incorrect.
Product
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-1220-2018·2018-09-12
AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information
PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.
Product
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-2963-2018·2018-09-12
Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implants because the inner package labels display incorrect item, lot, and size information.
Product
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2951-2018·2018-09-05
Haemonetics OrthoPAT Reservoirs Recalled Due to Missing Cannula
Haemonetics is recalling 348 OrthoPAT QuickConnect Reservoirs because a missing cannula prevents blood from being emptied and processed.
Product
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Category
Medical Device
Distribution
Distributed nationwide

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22601–22625 of 40175