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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18426–18450 of 27647

  • HighFDA (Devices)·Z-1221-2018·2018-04-04

    Inova Diagnostics Recalls QUANTA-Lyser 240 IFA Due to Power Supply Defect

    Inova Diagnostics is recalling one QUANTA-Lyser 240 IFA instrument because its power supply was not manufactured to specification, potentially causing loss of protective grounding.

    Product
    QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1197-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because they failed a clinical analysis showing surgical revision rates exceeded acceptance criteria.

    Product
    AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1252-2018·2018-04-04

    Stryker Recalls Orthopedic Cement Mixers Due to Sterility Assurance Issues

    Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1177-2018·2018-04-04

    ConMed Pediatric Defibrillation Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 pediatric defibrillation electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2018·2018-04-04

    Cook Inc. Recalls Marrs Laparoscopic GIFT Catheters Due to Quality Testing Gaps

    Cook Inc. is recalling 21 Marrs Laparoscopic GIFT Catheters because they were distributed without completed quality testing, posing a risk of nonviable embryos.

    Product
    Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound AC Adapter Recall for Fire Risk

    Konica Minolta is recalling 88 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage that may cause smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1248-2018·2018-04-04

    Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns

    Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1228-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed to meet clinical survivorship criteria.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2018·2018-04-04

    Stryker Recalls 30 Revolution 90 Degree Tibial Nozzles for Sterility Issues

    Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1192-2018·2018-04-04

    Zimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error

    Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length implants.

    Product
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1223-2018·2018-04-04

    Cook Vital-Port Vascular Access System Recall for Needle-Related Septum Damage

    Cook Vascular Inc. is recalling Vital-Port Vascular Access Systems because the included non-coring needle may cut or dislodge material from the device septum during initial implant.

    Product
    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1208-2018·2018-04-04

    Puritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect

    FDA is recalling 15,885 rechargeable lithium-ion batteries for Puritan Bennett 980 ventilators due to incorrect firmware that may prevent full charging.

    Product
    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2018·2018-04-04

    ConMed Recalls Mini Infant Radiotranslucent Electrodes Due to Adhesive Defect

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on the contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2018·2018-04-04

    Signia Power Handle Recalled for Shutting Down During Surgical Use

    Covidien LLC is recalling 2,121 Signia Power Handles because they reportedly shut down during use. The devices are used in various surgical procedures.

    Product
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2018·2018-04-04

    Stryker AutoPlex Bone Cement Recalled for Sterility Assurance Issues

    Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1195-2018·2018-04-04

    Roche Recalls cobas MRSA/SA Nucleic Acid Tests for Decreased Performance

    Roche Molecular Systems is recalling cobas MRSA/SA tests worldwide due to decreased performance that may lead to screening failures and potential infection spread.

    Product
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1245-2018·2018-04-04

    Stryker Recalls Femoral Canal Pressurizers Due to Sterility Assurance Issues

    Stryker is recalling specific lots of Femoral Canal Pressurizers because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1219-2018·2018-04-04

    DePuy Sigma HP Cemented Trochlear Implants Recalled for Elevated Revision Rates

    DePuy Orthopaedics is recalling specific Sigma HP Cemented Trochlear Implants due to elevated revision rates identified during post-market surveillance.

    Product
    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound Kit AC Adapter Recall

    Konica Minolta is recalling 17 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1255-2018·2018-04-04

    Stryker Recalls Intramedullary Brushes Due to Sterility Assurance Failure

    Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.

    Product
    Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1186-2018·2018-04-04

    Cook Inc. Recalls IVF Intratubal Transfer Sets Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of Echosight Jansen-Anderson Intratubal Transfer Sets because they were distributed without completed quality testing, posing a risk of nonviable embryos.

    Product
    Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide