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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

35176–35200 of 40325

  • HighFDA (Devices)·Z-2232-2014·2014-08-20

    BioMerieux Recalls VIDAS D-Dimer Exclusion II Test Kits

    BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.

    Product
    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2205-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2175-2014·2014-08-20

    Agfa Healthcare Recalls DX-D 600 Imaging Packages Due to Crane Movement

    Agfa Healthcare is recalling 17 DX-D 600 imaging packages because the overhead tube crane may move uncontrolled. Customers should stop using the equipment.

    Product
    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2223-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasps Due to Handle Failure

    Zimmer, Inc. is recalling 412 units of nonsterile orthopedic rasps because the handle may fail to remain assembled during use.

    Product
    Vl DBL OFFST WI LRG STPL, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk

    Medical Positioning Inc. is recalling Model # 1219 HUT tables because a defective component may cause the table to drop rapidly into the Trendelenburg position under excessive weight.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2014·2014-08-20

    Gambro Recalls Prisma M100 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2221-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles that may fail to remain assembled during use.

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2014·2014-08-20

    Gambro Recalls Prisma M60 Postdilution Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M60 POSTDILUTION sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2215-2014·2014-08-20

    Zimmer Recalls Moore Hip Prosthesis Stems Due to Packaging Failures

    Zimmer, Inc. is voluntarily recalling 68 units of Moore Hip Prosthesis Long Fenestrated Stems because packaging design verification tests failed, allowing stems to breach package trays.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2014·2014-08-20

    Nanosphere Recalls Verigene CDF Amplification Trays Due to Increased Error Rates

    Nanosphere is recalling specific lots of Verigene CDF Amplification Trays because they produced an increased rate of 'No Call - INT CTL 2' results when testing negative samples.

    Product
    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2189-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2169-2014·2014-08-20

    Abbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect

    Abbott Molecular is recalling 5 mL Reaction Vessels for the m2000sp system because an insufficient rim may cause the vessels to drop through the carrier.

    Product
    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2186-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions

    Codman & Shurtleff is recalling 9,498 implantable valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.

    Product
    Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2181-2014·2014-08-20

    Beevers Recalls Luma Wrap Phototherapy Swaddlers for Regulatory Misclassification

    Beevers Manufacturing is recalling Luma Wrap neonatal phototherapy swaddlers because they were marketed without a required FDA 510(k) clearance.

    Product
    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2170-2014·2014-08-20

    Nanosphere Recalls Verigene Gram-Negative Blood Culture Test Cartridges

    Nanosphere is voluntarily recalling Verigene Gram-Negative Blood Culture Test Cartridges due to an elevated risk of No Call and False Negative results.

    Product
    Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2184-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2214-2014·2014-08-20

    Ortho-Clinical VITROS Chemistry Calibration Modules Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM Calibration Data Modules because they prevent the calibration and use of specific ammonia test slides.

    Product
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2191-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid)…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2237-2014·2014-08-20

    Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error

    Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.

    Product
    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the…
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2236-2014·2014-08-20

    Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles

    Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.

    Product
    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2179-2014·2014-08-20

    Medtronic MiniMed Guardian Monitor Recall for Water Resistance Issue

    Medtronic MiniMed is recalling 86 Guardian REAL-Time monitors due to a manufacturing issue that may compromise water resistance.

    Product
    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2187-2014·2014-08-20

    Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2190-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2235-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch

    Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.

    Product
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2171-2014·2014-08-20

    Intuitive Surgical Recalls EndoWrist Stapler Manuals for pH Specification Change

    Intuitive Surgical is recalling EndoWrist Stapler 45 User Manual Addenda and Wall Charts to correct the pH range specification for enzymatic cleaners.

    Product
    EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General…
    Category
    Medical Device
    Distribution
    2 states