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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35151–35175 of 40449

  • HighFDA (Devices)·Z-2545-2014·2014-09-03

    Zimmer Patello-Femoral Knee Prosthesis Recalled for Forging Defects

    Zimmer, Inc. is recalling 15 units of a specific knee prosthesis component because internal review found five raw material forgings with defects that were not segregated.

    Product
    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2014·2014-09-03

    Zimmer Persona Distal Valgus Alignment Guide Recalled for Mechanical Defect

    Zimmer, Inc. is recalling 2,248 units of the Persona Distal Valgus Alignment Guide because the collet locks are seizing in the unlocked position.

    Product
    Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2542-2014·2014-09-03

    BD Vacutainer CPT Cell Preparation Tubes Recalled for Poor Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer CPT Cell Preparation Tubes due to poor separation that reduces the number of recovered mononuclear cells.

    Product
    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2555-2014·2014-09-03

    Thermedx Fluid Management System Recalled for Canister Ring Manufacturing Change

    Thermedx LLC is recalling 21 units of the P4000 Fluid Management System because a manufacturing change to the canister ring may cause the deficit display to read higher than the actual fluid deficit.

    Product
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2558-2014·2014-09-03

    Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak

    Civco Medical Instruments is recalling 52 kits of CollectEVAC sterile devices because a pinhole leak in the packaging could compromise sterility.

    Product
    CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2549-2014·2014-09-03

    Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures

    Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2552-2014·2014-09-03

    Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures

    Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device sterility.

    Product
    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2550-2014·2014-09-03

    Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures

    Zimmer, Inc. is recalling specific trauma tubes and plates because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2548-2014·2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2546-2014·2014-09-03

    Zimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of knee fixation screws worldwide because packaging design verification tests failed, potentially compromising sterility.

    Product
    Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2547-2014·2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2559-2014·2014-09-03

    Nanosphere Recalls Verigene CYP2C19 Nucleic Acid Test Kits

    Nanosphere is recalling 78 Verigene CYP2C19 Nucleic Acid Test kits due to an unacceptable increase in initial no-call rates.

    Product
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2261-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2254-2014·2014-08-27

    Ortho Development Recalls Knee Implant Components Due to Sealing Defects

    Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.

    Product
    Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2192-2014·2014-08-27

    FDA Recalls Gel-E Donut and Squishon Baby Pillows Due to Mold

    Childrens Medical Ventures is recalling Gel-E Donut and Squishon 2 gel pillows because of visible mold. The mold was identified as Cladosporium and Penicillium fungi.

    Product
    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2148-2014·2014-08-27

    DePuy Synthes Recalls Craniomaxillofacial Distraction System Due to Reversal Risk

    Synthes, Inc. is recalling specific lots of the DePuy Synthes Craniomaxillofacial Distraction System because the devices may reverse after surgery.

    Product
    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2256-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2014·2014-08-27

    GE Healthcare Recalls Discovery XR656P/N Wall Stand Systems Due to Hook Failure

    GE Healthcare is recalling 334 Discovery XR656P/N wall stand systems because nylon hooks supporting the detector may fail, causing the detector to fall.

    Product
    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-2260-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 non-sterile Persona Tibial General Instrument Trays because a geometry defect may prevent proper sterilization of included drill guides.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2240-2014·2014-08-27

    TomoTherapy H Series Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2014·2014-08-27

    TomoTherapy Hi-Art Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2014·2014-08-27

    ICU Medical Recalls Port Access Kits with Potential Sterility Issues

    ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.

    Product
    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2014·2014-08-27

    Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers

    Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.

    Product
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
    Category
    Medical Device
    Distribution
    6 states