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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24851–24875 of 27722

  • 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
  • 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
  • SevereFDA (Devices)·Z-2112-2014·2014-08-06

    Wellspring Recalls IPM Wound Gel Rx Wound Dressing Due to Microbial Contamination

    Wellspring Pharmaceutical is recalling IPM Wound Gel Rx Wound Dressing due to a potential for microbial contamination. The product is distributed in the US and Canada.

    Product
    IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2122-2014·2014-08-06

    Stryker InTouch Critical Care Bed Recall Due to Caster Failure

    Stryker is recalling InTouch Critical Care Beds because casters may break and fall off, potentially affecting brake functions.

    Product
    InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
    Category
    Medical Device
    Distribution
    Distributed nationwide