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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35301–35325 of 40449

  • LowFDA (Devices)·Z-2176-2014·2014-08-20

    Agfa Digital Radiography X-Ray System Recalled for Mislabeled Output Power

    AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit in West Virginia because it was mislabeled with a factory label showing 32 KW output power.

    Product
    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2159-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2164-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2162-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2137-2014·2014-08-13

    Carestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure

    Carestream Health is recalling KODAK DirectView DR 9000 systems because a control failure may cause the U-Arm to move downward unexpectedly at three times the normal speed.

    Product
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2014·2014-08-13

    Stryker Recalls Sonopet Ultrasonic Surgical Systems Due to Irrigation Defect

    Stryker is recalling 2,460 Sonopet Ultrasonic Surgical Systems because insufficient irrigation to the tip can potentially lead to excessive heat.

    Product
    Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2014·2014-08-13

    Ortho VITROS 4600 Chemistry System Recalled for Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak

    ICU Medical is recalling 100 units of Transpac IT arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2151-2014·2014-08-13

    Coltene Whaledent Recalls Latex Dental Dams Labeled as Non-Latex

    Coltene Whaledent Inc. is recalling latex dental dams that were incorrectly packaged in non-latex packaging, posing a risk to patients with latex allergies.

    Product
    Latex Dental Dams labeled as Non-Latex Dental Dams
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2165-2014·2014-08-13

    ICU Medical Recalls Transpac Arterial Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 50 units of Transpac arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2158-2014·2014-08-13

    ICU Medical Recalls Trifurcated Transpac IT Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 40 units of Trifurcated Transpac IT Monitoring Kits because a component connection may crack and cause a fluid leak.

    Product
    Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2153-2014·2014-08-13

    PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments

    PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.

    Product
    Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2014·2014-08-13

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac IV Trifurcated Monitoring Kits because a component connection may crack, causing a fluid leak.

    Product
    Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2160-2014·2014-08-13

    ICU Medical Recalls Trifurcated Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Trifurcated Transpac IV Monitoring Kits because a component connection may crack and cause a fluid leak.

    Product
    Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2166-2014·2014-08-13

    PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk

    PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.

    Product
    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2146-2014·2014-08-13

    Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

    Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

    Product
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2161-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling 200 arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2138-2014·2014-08-13

    Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure

    Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.

    Product
    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2139-2014·2014-08-13

    Ortho VITROS 3600 Immunodiagnostic System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, &…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2014·2014-08-13

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2149-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2014·2014-08-13

    BioMerieux VIDAS TPSA Diagnostic Recalled for Unauthorized Distribution

    BioMerieux SA is recalling 1,902 units of VIDAS TPSA in vitro diagnostic tests because the product is not approved or authorized for distribution in the US.

    Product
    VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2136-2014·2014-08-13

    X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery

    X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.

    Product
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2144-2014·2014-08-13

    Zimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error

    Zimmer, Inc. is recalling Tapered Screw-Vent Dental Implants because the inner vial is labeled with incorrect dimensions.

    Product
    Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2014·2014-08-13

    Boston Scientific recalls 21 ENDOTAK RELIANCE defibrillation leads due to test errors

    Boston Scientific is recalling 21 ENDOTAK RELIANCE defibrillation leads because manufacturing test records showed suspected data recording errors. No injuries have been reported.

    Product
    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter…
    Category
    Medical Device
    Distribution
    Distributed nationwide