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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31726–31750 of 40449

  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2016·2015-11-04

    Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2016·2015-11-04

    Nipro Safe Touch TULIP Safety Fistula Needle Packaging Error Recall

    Nipro Medical Corporation is recalling 50,000 fistula needles because some 1 1/4-inch needles were packaged in 1-inch blister packs.

    Product
    Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0172-2016·2015-11-04

    Spacelabs CardioCall ECG Event Recorders Recalled for Battery Defect

    Spacelabs Healthcare is recalling CardioCall ECG Event Recorders because a battery defect causes continuous ringing and prevents normal operation.

    Product
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0165-2016·2015-11-04

    Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling

    Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.

    Product
    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Devices)·Z-0171-2016·2015-11-04

    BD CD3 FITC Recalled for Spanish Labeling Error

    Becton, Dickinson and Company is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic reagents due to an error in the Spanish small text on the label.

    Product
    BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2016·2015-10-28

    Elekta XiO Radiation Treatment Planning System Recalled for Incorrect Treatment Delivery

    Elekta is recalling 1,440 XiO Radiation Treatment Planning Systems because they may deliver incorrect treatments when using third-party fixed wedges.

    Product
    XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0158-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,246 units of the MOSAICPLASTY DP Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2016·2015-10-28

    ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling iDuo Bicompartmental Knee Replacement Systems due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 603 units of the MOSAICPLASTY DP Disposable Harvesting System because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2016·2015-10-28

    ConFormis iDUO G2 Knee Implant Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling one unit of the ConFormis iDUO G2 knee implant due to potential ethylene glycol residue.

    Product
    ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2016·2015-10-28

    ConForMIS iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 313 units of the iTotal CR Knee Replacement System due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2016·2015-10-28

    Baxter Recalls Microbore Catheter Extension Sets Due to Potential Leak

    Baxter Healthcare Corp is recalling 23,600 units of One-Link Microbore Catheter Extension Sets due to a potential leak at the tubing to luer bond.

    Product
    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0141-2016·2015-10-28

    ConForMIS iUni Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 68 iUni Unicondylar Knee Replacement Systems due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2016·2015-10-28

    ConForMIS iUni Knee Replacement System Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 7 units of the iUni Unicondylar Knee Replacement System due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2016·2015-10-28

    Cardinal Health Recalls Ambitex NMD400 Nitrile Exam Gloves Due to Leak Test Failure

    Cardinal Health is recalling Ambitex NMD400 Nitrile Exam Gloves (size medium) because samples failed FDA water leak tests, compromising their barrier function.

    Product
    Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0154-2016·2015-10-28

    Berchtold TELETOM Equipment Management System Recall for Control Malfunction

    Berchtold Corp. is recalling TELETOM Equipment Management Systems 4 and 6 series due to potential control and brake failure caused by fluid intrusion.

    Product
    TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling MOSAICPLASTY DP- Disposable Harvesting Systems because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0131-2016·2015-10-28

    Encore Medical Recalls AltiVate Humeral Socket Shell Trial Due to Assembly Issues

    Encore Medical is recalling 20 units of the AltiVate Humeral Socket Shell Trial because the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw.

    Product
    AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0143-2016·2015-10-28

    ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 12 units of the iDuo Knee Bicompartmental Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2016·2015-10-28

    Smiths Medical Recalls Port-A-Cath Needles Due to Incorrect Labeling

    Smiths Medical ASD, Inc. is recalling Port-A-Cath Plastic Hub Needles from Lot 46262 because the lid stock labels contain incorrect part numbers, descriptions, and images.

    Product
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0147-2016·2015-10-28

    ConFormis iTotal Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS is recalling 110 units of the iTotal Posterior Stabilized Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0137-2016·2015-10-28

    Biomet Thinflap System Cases Recalled Due to Lid Opening Difficulty

    Biomet Microfixation is recalling 5 Thinflap System Cases because the lids require excessive force to open.

    Product
    Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0134-2016·2015-10-28

    Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error

    Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast process not identified in the manufacturing specification.

    Product
    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide