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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21501–21525 of 27699

  • HighFDA (Devices)·Z-1999-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling 328 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specifications that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1959-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to a potential for polystyrene particulate presence.

    Product
    BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1987-2016·2016-06-22

    Navilyst Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 190 units of BioFlo Hybrid PICC catheters because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2016·2016-06-22

    Navilyst Medical Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 150 units of Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1964-2016·2016-06-22

    Staar Surgical Recalls STAAR AQ Cartridge-FP Intraocular Lens Delivery Systems

    Staar Surgical Co. is recalling 2,612 units of the STAAR AQ Cartridge-FP because the device may crack during loading or delivery of intraocular lenses.

    Product
    STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1916-2016·2016-06-15

    Hill-Rom Recalls Liko Universal SlingBars Due to Center Bolt Failure Risk

    Hill-Rom is recalling Liko Universal SlingBars because the center bolt may weaken and break, posing a risk of patient falls and injury.

    Product
    Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2016·2016-06-15

    Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error

    Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.

    Product
    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1922-2016·2016-06-15

    Baxter Recalls Actifuse Bone Void Fillers Due to Endotoxin Concerns

    Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.

    Product
    Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2016·2016-06-15

    GE Revolution CT Patient Table Recalled for Unintended Motion Risk

    GE Healthcare is recalling Revolution CT Patient Tables because the cradle can descend on its own, posing a crushing risk to large patients.

    Product
    GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1832-2016·2016-06-15

    Hospira Recalls 1,490 Plum 360 Infusion Pumps Due to Calibration Error

    Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.

    Product
    The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1912-2016·2016-06-15

    DePuy Synthes Flexible Shaft Reamers Recalled for Cytotoxicity Failure

    Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.

    Product
    DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2016·2016-06-15

    Zimmer Biomet Recalls Persona Trabecular Metal Tibial Plate Instruments

    Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.

    Product
    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1925-2016·2016-06-15

    Berchtold Recalls Surgical Table Cushions Due to Potential Staple Contamination

    Berchtold Corp. is recalling 227 HybriGel surgical table cushions because they may contain staples that could appear on patient x-rays.

    Product
    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2016·2016-06-15

    Philips Healthcare Ingenuity Core128 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1937-2016·2016-06-15

    Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities

    Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

    Product
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2016·2016-06-15

    Sedecal Mobile X-ray System Recalled for Software Defect

    Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.

    Product
    Sedecal SA Mobile Diagnost w DR x-ray system
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1936-2016·2016-06-15

    Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues

    Becton Dickinson is recalling 176,000 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

    Product
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2016·2016-06-15

    Philips Brilliance 64 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states