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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29501–29525 of 40325

  • ModerateFDA (Devices)·Z-2322-2016·2016-08-10

    Zimmer Biomet Recalls Twist Drills Due to Tolerance Issues

    Zimmer Biomet is voluntarily recalling 169 Twist Drills and V-Tek Twist Drills because of a potential tolerance stack-up issue with Kirschner Wire components.

    Product
    TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2314-2016·2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2016·2016-08-10

    Medtronic Navigation Recalls S7 MACH FrameLink Software Applications

    Medtronic Navigation is conducting a voluntary field action for S7 MACH FrameLink software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2016·2016-08-10

    Beckman Coulter AU680 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU680 Chemistry Analyzers because leaking and cracked C cups can cause coolant to leak onto circuit boards, resulting in short-circuits and instrument stop mode.

    Product
    AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2333-2016·2016-08-10

    C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues

    C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.

    Product
    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2327-2016·2016-08-10

    Teleflex Horizon 24 Titanium Clips Recalled for Missing Date Labels

    Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack labels.

    Product
    Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip…
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-2311-2016·2016-08-10

    Branan Medical Recalls AmediCheck Instant Test Cups Due to Packaging Error

    Branan Medical is recalling AmediCheck Instant Test Cups because they may erroneously contain 12-panel cups due to a packaging error.

    Product
    AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2291-2016·2016-08-03

    Moller Vital Molift Air Ceiling Hoist Recall for Loose Bolt Risk

    Moller Vital is recalling Molift Air ceiling hoists because the suspension coupling bolt may come loose, posing a risk of patient falls.

    Product
    Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2281-2016·2016-08-03

    Stryker Trident Constrained Liner Inserter Impactor Tip Recall

    Stryker is recalling Trident Constrained Liner Inserter Impactor Tips because they do not meet required sterility assurance levels when steam sterilized.

    Product
    Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2236-2016·2016-08-03

    GE Phoenix v|tome|x m240 X-Ray Systems Recalled for Radiation Emissions

    GE Inspection Technologies is recalling four Phoenix v|tome|x m240 cabinet x-ray systems because radiation emissions exceeded safety limits due to insufficient door shielding.

    Product
    GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2212-2016·2016-08-03

    BD Recalls Diamond-Flex Retractors Due to Weld Failure Risk

    BD is recalling specific Diamond-Flex Circular Retractors because a weld failure could cause wire protrusion, potentially damaging tissue or organs during use.

    Product
    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2290-2016·2016-08-03

    Sunrise Medical Recalls Quickie Q7 Wheelchairs Due to Backrest Bracket Failure

    Sunrise Medical is recalling Quickie Q7 wheelchairs because the backrest bracket can fracture, causing the backrest to detach from the chair frame.

    Product
    Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2293-2016·2016-08-03

    Elekta Recalls MOSAIQ Oncology System Due to Potential Dosing Errors

    Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2016·2016-08-03

    Ortho-Clinical VITROS Calcium Slides Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.

    Product
    VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling container fill and transfer sets because they cannot meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2300-2016·2016-08-03

    Ge Healthcare Recalls Imagecast PACS Software Due to Image Context Defect

    Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.

    Product
    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling container fill and transfer sets because they may not meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2296-2016·2016-08-03

    Integra External Fixation System Rocker Bottom Recall for Loose Silicone Insert

    Integra LifeSciences Corp. is recalling 27 units of the External Fixation System Rocker Bottom because the embedded silicone insert may become dislodged or loose.

    Product
    Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2292-2016·2016-08-03

    Zimmer Avenir Moller Hip Stem Recall Due to Packaging Mix-up

    Zimmer GmbH is recalling two Avenir Moller hip stem models due to a packaging mix-up that could lead to the use of the incorrect implant.

    Product
    Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2016·2016-08-03

    Beckman Coulter Allegra X-5 Rotor Yoke Recalled for Defect

    Beckman Coulter is recalling Allegra X-5 rotor yokes because a defect allows improper rotor seating, which could lead to rotor failure if buckets are loaded in an imbalanced configuration.

    Product
    Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2016·2016-08-03

    Draeger Babytherm Infant Warmers Recalled for Skin Temperature Mode Risk

    Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.

    Product
    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2264-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, 250 mL and 500 mL, . .
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2283-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.

    Product
    Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide