The Recall Desk

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.

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22676–22700 of 40339

  • 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
  • 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-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
  • SevereFDA (Devices)·Z-2926-2018·2018-09-05

    Stanbio AC Power Adapter Recall for HemoPoint H2 Meter

    Stanbio Laboratory is recalling AC power adapters for the HemoPoint H2 meter because the adapter plate may crack or detach, exposing live electrical contacts.

    Product
    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2878-2018·2018-09-05

    Biosense Webster Recalls WaveCrest Left Atrial Appendage Occlusion System Devices

    Biosense Webster is recalling 25 units of the WaveCrest Left Atrial Appendage Occlusion System (32 mm) because the delivery sheath may buckle during recapture.

    Product
    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2941-2018·2018-09-05

    MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2937-2018·2018-09-05

    MedComp Duo-Flow XTP Straight Full Set Recalled for Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow XTP Straight Full Sets because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2947-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2958-2018·2018-09-05

    FDA Recalls Li-ion Battery Packs for BIS Monitoring Systems

    The FDA is recalling Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems due to a Class II safety issue.

    Product
    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2955-2018·2018-09-05

    GE Carestation 30 Anesthesia Systems Recalled for Gas Switch Defect

    GE Medical Systems is recalling 252 Carestation 30 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE Carestation 30 anesthesia systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2954-2018·2018-09-05

    GE Carestation Anesthesia Systems Recalled for Gas Switch Defect

    GE Medical Systems is recalling 310 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
    Category
    Medical Device
    Distribution
    0 states