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

39101–39125 of 40449

  • ModerateFDA (Devices)·Z-0642-2013·2013-01-16

    Philips HeartStart FRx AED Recall for Maintenance Manual Clarification

    Philips is recalling HeartStart FRx AEDs to clarify maintenance instructions in the Owner's Manual.

    Product
    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0646-2013·2013-01-16

    Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues

    Siemens Healthcare Diagnostics is recalling specific lots of Coat-A-Consta IRMA TSH calibrators due to confirmed under-recovery of dose values.

    Product
    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0641-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Failure

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0635-2013·2013-01-16

    Siemens Chek-Stix Urine Control Strips Recalled for Temperature Sensitivity

    Siemens Healthcare Diagnostics is recalling Chek-Stix Positive and Negative Control Strips for Urine Chemistry because the leukocyte result may become inaccurate if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0639-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling specific lots of Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0665-2013·2013-01-16

    Siemens Emit Tox Serum Calibrators Recalled for Incorrect Expiration Date

    Siemens Healthcare Diagnostics is recalling 1,998 cartons of Emit Tox Serum Calibrators because an incorrect expiration date was assigned to Lot D1.

    Product
    Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0638-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0620-2013·2013-01-09

    SynCardia Recalls Companion External Batteries Due to Thermal Event Risk

    SynCardia Systems is recalling Companion External Batteries used with the Companion 2 Driver System because they may be at risk of thermal events or physical damage.

    Product
    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0622-2013·2013-01-09

    Hill-Rom Recalls Liko Standard Slingbar 450 Due to Injury Reports

    Hill-Rom is recalling 261 Liko Standard Slingbar 450 units after receiving reports of serious injuries. The device is used with ceiling and mobile patient lifts.

    Product
    Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0628-2013·2013-01-09

    Stryker Medical Surgical Beds Recalled for Brake Ring Defect

    Stryker is recalling 9 Model 3002SEX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

    Product
    Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0624-2013·2013-01-09

    Hospira Recalls Plum A+ Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 297,833 Plum A+ infusion pumps because a door roller assembly may break, causing unrestricted flow or over-delivery of IV fluids.

    Product
    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0621-2013·2013-01-09

    Fisher & Paykel Healthcare Recalls Reusable Breathing Circuits Due to Hole Damage

    Fisher & Paykel Healthcare is recalling specific lots of reusable breathing circuits because tube hole damage could cause gas leaks and loss of pressure during oxygen therapy.

    Product
    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0625-2013·2013-01-09

    Hospira Recalls Plum A+3 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 28,599 Plum A+3 infusion pumps worldwide because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of IV medication.

    Product
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0623-2013·2013-01-09

    B. Braun Recalls Infusomat Space Pump Pole Clamps Due to Breakage Risk

    B. Braun Medical is recalling 13,078 Infusomat Space Pump Pole Clamps because the locking grids may break.

    Product
    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2013·2013-01-09

    Stryker Medical Surgical Beds Recalled for Brake Ring Defect

    Stryker is recalling Model 3002S3EX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

    Product
    Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2013·2013-01-09

    Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer

    Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.

    Product
    PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2013·2013-01-09

    Mindray DPM Central Station Recalled for Patient Data Anomaly

    Mindray is recalling two DPM Central Station units due to a software anomaly that may replace one patient's trend data with another's.

    Product
    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2013·2013-01-09

    Medtronic Intersept Custom Tubing Packs Recalled for Packaging Damage

    Medtronic is recalling Intersept Custom Tubing Packs because packaging trays may be damaged, compromising product sterility.

    Product
    Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2013·2013-01-09

    Maquet Yuno Extension Table Device Recalled for Screw Tension Issue

    Maquet Inc. is recalling 63 Yuno Extension Table Devices due to a potential issue with the screw tension of the extension device.

    Product
    Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0632-2013·2013-01-09

    Horiba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent

    Horiba Medical is recalling ABX PENTRA AST CP reagent because it recorded incorrect low values for high AST levels without triggering an alarm.

    Product
    ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2013·2013-01-09

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 180 Plum A+ Hyperbaric Infusion Pumps because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of medication.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0634-2013·2013-01-09

    Abbott m2000sp Instrument Software Recall for Data Saving Error

    Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.

    Product
    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2013·2013-01-09

    Cooper Vision Recalls AVAIRA Toric Contact Lenses for Silicone Oil Residue

    Cooper Vision is recalling 246 units of AVAIRA Toric Contact Lenses because they exceeded the acceptance limit for silicone oil residual.

    Product
    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0619-2013·2013-01-09

    HemoCue Urine Analyzer Recall for Missing Documentation

    HemoCue AB is recalling 48 urine analyzers because they were shipped with the wrong Quick Reference Guide and a missing warranty statement.

    Product
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents…
    Category
    Medical Device
    Distribution
    17 states