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

25351–25375 of 40357

HighFDA (Devices)·Z-0313-2018·2018-01-10
Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Mechanism Defect
Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Product
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0316-2018·2018-01-10
Amendia Recalls Ceres Self-Drilling Variable Screws Due to Incorrect Length Marking
Amendia, Inc. is recalling 40 Ceres Self-Drilling Variable Screws because some units marked as 12 mm actually measure 14 mm in length.
Product
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0311-2018·2018-01-10
Philips Mobile Detector Holder Recalled Due to Potential Detector Drop Hazard
Philips is recalling 412 Mobile Detector Holders for Stationary X-ray Systems because the lock mechanism may fail, causing the detector to drop.
Product
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0315-2018·2018-01-10
Centurion Recalls Convenience Kits Contaminated with Particulate Matter
Centurion Medical Products is recalling specific lots of convenience kits containing BD SafetyGlide needles due to particulate contamination.
Product
SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0298-2018·2018-01-10
Zimmer Biomet Recalls Hip Fracture Stem Due to Internal Label Error
Zimmer Biomet is recalling specific hip fracture stems because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0304-2018·2018-01-10
Zimmer Biomet Recalls Femoral Distal Assembly Due to Internal Labeling Error
Zimmer Biomet is recalling specific femoral distal assemblies because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0303-2018·2018-01-10
Zimmer Biomet Recalls OSS Cemented IM Stem Due to Labeling Error
Zimmer Biomet is recalling specific OSS Cemented IM Stem units because the internal patient label may be incorrect, although the outer box and product itself are correctly identified.
Product
OSS CEMENTED IM STEM 12X150, model # 150366
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0302-2018·2018-01-10
Zimmer Biomet Recalls CER BIOLOXD OPTION HD 32MM Due to Labeling Error
Zimmer Biomet is recalling CER BIOLOXD OPTION HD 32MM implants because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
CER BIOLOXD OPTION HD 32MM, model # 650-1056
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0307-2018·2018-01-10
Smiths Medical CADD-Legacy 1 Pumps Recalled for Serial Number Mismatch
Smiths Medical ASD Inc. is recalling 58 CADD-Legacy 1 Ambulatory Infusion Pumps because the physical label may not match the serial number programmed into the device software.
Product
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0300-2018·2018-01-10
Zimmer Biomet Recalls ECHO POR FMRL NC 9X125 Due to Labeling Error
Zimmer Biomet is recalling ECHO POR FMRL NC 9X125 medical devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
ECHO POR FMRL NC 9X125, model # 192009
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0305-2018·2018-01-10
Zimmer Biomet Recalls Distal Femoral Knee Implant Due to Labeling Error
Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.
Product
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0296-2018·2018-01-10
Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp units because the internal patient label may be incorrect, though the product itself is correct.
Product
Lateral Troch Plate Full Crimp - 254mm, model # 350837
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0314-2018·2018-01-10
Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening
Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Product
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0301-2018·2018-01-10
Zimmer Biomet Recalls CER OPTION TYPE 1 TPR SLEVE -6 Due to Labeling Error
Zimmer Biomet is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0306-2018·2018-01-10
Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation
Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.
Product
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0297-2018·2018-01-10
Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
Lateral Troch Plate Full Crimp - 254mm, model # 350838
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0299-2018·2018-01-10
Zimmer Biomet Recalls COMP Primary Stem Due to Labeling Error
Zimmer Biomet is recalling COMP Primary Stem 8MM MINI devices because the internal patient label may be incorrect, although the product itself is correctly identified.
Product
COMP PRIMARY STEM 8MM MINI, model # 113628
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0312-2018·2018-01-10
Zimmer Biomet Recalls PPS RingLoc+ Acetabular Shells Due to Missing Etching
Zimmer Biomet is recalling 15 units of PPS RingLoc+ Acetabular Shells because the product was distributed with missing etching.
Product
PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+…
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-0308-2018·2018-01-10
Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk
Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.
Product
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0310-2018·2018-01-10
Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk
Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.
Product
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0309-2018·2018-01-10
Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk
Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.
Product
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0213-2018·2018-01-03
Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.
Product
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0289-2018·2018-01-03
Accuray TomoHDA System Recalled for Uncontrolled Couch Movement
Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.
Product
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0288-2018·2018-01-03
Accuray TomoH System Recalled for Uncontrolled Couch Movement
Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.
Product
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0286-2018·2018-01-03
Accuray Hi-Art System Recalled for Uncontrolled Couch Movement
Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.
Product
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
Category
Medical Device
Distribution
0 states

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