The Recall Desk

Archive

June 2018 recalls

577 recalls were announced in June 2018.

What the numbers show

Critical
17
Severe
142
High
282
Moderate
123
Low
13

Of the 577 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

1–100 of 577

  • CriticalUSDA FSIS·057-2018·2018-06-29

    L&D Market Recalls Wasabi Chicken Wraps for Undeclared Milk Allergen

    L&D Market Inc. is recalling wasabi chicken wraps due to misbranding and undeclared milk allergens. The products were shipped to retail locations in Cambridge, Massachusetts.

    Product
    L&D Market Inc. — L&D Market, Inc. Recalls Chicken Wrap Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighCPSC·18750·2018-06-29

    BRP Recalls 2018 Can-Am ATVs Due to Fuel Leak and Fire Hazard

    BRP is recalling about 13,300 2018 Can-Am Outlander and Renegade ATVs because fuel can spray from the tank when opening the gas cap, posing a fire hazard.

    Product
    2018 Can-Am Outlander and Renegade all-terrain vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18751·2018-06-29

    Helmets R Us Recalls Rollerblade Helmets Due to Head Injury Risk

    Helmets R Us is recalling about 9,700 Rollerblade helmets sold to schools because they fail to meet federal safety standards, posing a risk of head injury.

    Product
    Rollerblade® helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V439000·2018-06-28

    BMW Recalls 2018 X5 and X6 Models for Front Control Arm Defect

    BMW is recalling 2018 X5 and X6 vehicles because a front lower-left control arm pivot bolt may not be properly hardened, potentially causing the arm to break and increasing crash risk.

    Product
    BMW — BMW X6, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V437000·2018-06-28

    GM Recalls 2016-2018 Cadillac CT6 Models for Child Seat Anchor Defect

    General Motors is recalling 2016-2018 Cadillac CT6 vehicles because excess adhesive on child seat anchorage bars may interfere with proper installation, increasing injury risk.

    Product
    CADILLAC — CADILLAC CT6, CT6 PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2253-2018·2018-06-27

    Draeger Apollo Anesthesia Machine Recalled for Potential Hypoxic Gas Delivery

    Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.

    Product
    Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2250-2018·2018-06-27

    Draeger Fabius GS Premium Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2252-2018·2018-06-27

    Draeger Fabius GS MRI Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.

    Product
    Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2251-2018·2018-06-27

    Draeger Fabius GS Tiro Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.

    Product
    Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0885-2018·2018-06-27

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.

    Product
    5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0883-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0881-2018·2018-06-27

    ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2238-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 11 trauma guide wires due to packaging defects that may compromise sterility, posing an infection risk.

    Product
    G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V435000·2018-06-27

    Altec Recalls 2017 Aerial Devices Due to Fastener Corrosion Risk

    Altec is recalling 153 2017 aerial devices because high-strength fasteners may corrode and fail, potentially causing the pedestal to separate from the vehicle.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2234-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 449 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0882-2018·2018-06-27

    ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2254-2018·2018-06-27

    Draeger Perseus A500 Anesthesia Machine Recalled for Hypoxic Mixture Risk

    Draeger Medical is recalling 33 Perseus A500 anesthesia machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2271-2018·2018-06-27

    CryoLife Recalls Cryovalve SG Pulmonary Human Heart Valve

    CryoLife, Inc. is recalling one unit of the Cryovalve SG Pulmonary Human Heart Valve because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.

    Product
    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2269-2018·2018-06-27

    Olympus JF-140F Duodenoscopes Recalled for New Reprocessing Procedures

    Olympus is recalling 994 JF-140F duodenoscopes nationwide to implement new reprocessing procedures following reported patient infections.

    Product
    Olympus JF-140F duodenoscopes (Model NumberJF-140F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1583-2018·2018-06-27

    Melissa's Spicy Edamame Recalled for Undeclared Oyster Sauce Allergen

    World Variety Produce Inc. is recalling Melissa's Spicy Edamame because the included flavoring packet contains oyster sauce, an undeclared allergen.

    Product
    Melissa's Spicy Edamame: Lightly seasoned with Japanese Chile and Sesame Oil. 7 oz. (1.98g) Keep Refrigerated UPC: 0-45255-14637 6 count and 12 count cases; Ingredients: Soybeans, water Sesame oil, Soy Sauce (soy Beans, Wheat and salt) Rice Wine vinegar, Chaotian chile, p
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2255-2018·2018-06-27

    Cyberonics VNS Therapy Programmer Model 3000 Recalled for Parameter Miscalculation

    Cyberonics is recalling 252 VNS Therapy Programmer Model 3000 units because certain programming events can miscalculate parameters for implanted generators, potentially causing painful stimulation or lack of therapy.

    Product
    VNS Therapy Programmer, Model 3000, v1.0 System
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2262-2018·2018-06-27

    TriMed Recalls Nitinol Staples Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.

    Product
    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2266-2018·2018-06-27

    Datex-Ohmeda CARESCAPE R860 Ventilators Recalled for Display Processor Failure

    Datex-Ohmeda is recalling CARESCAPE R860 ventilators with software version 10SP05 because the display processor may experience unexpected failure.

    Product
    CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocess
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Packaging Defects

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1593-2018·2018-06-27

    H-E-B Sliced Salad Olives Recalled for Glass Contamination

    Agro Sevilla USA is recalling H-E-B Ode to Olives, Sliced Salad Olives, because two jars were found to contain pieces of glass. No injuries have been reported.

    Product
    H-E-B Ode to Olives, Sliced Salad Olives, 10 oz. drained weight per jar/ 6 jars per case (this product is sold by the jar at the store level, not by the case), Best by November 3, 2019.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2242-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 2,396 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2248-2018·2018-06-27

    Siemens Biograph mCT Systems Recalled Due to Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 405 Biograph mCT systems because laser cover windows may fall off, posing a potential hazard.

    Product
    Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2237-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 832 trauma guide wires because packaging defects may compromise sterility, posing a risk of infection.

    Product
    G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2018·2018-06-27

    CryoLife Pulmonary Cardiac Branch Recalled Due to Morphine Presence

    CryoLife, Inc. is recalling one unit of Cryopatch SG Pulmonary Human Cardiac Branch because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.

    Product
    Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2246-2018·2018-06-27

    Synthes Graphic Case F/6.5mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set because the screw gauges measure 5.41mm shorter than the actual screw length.

    Product
    Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2247-2018·2018-06-27

    Synthes Graphic Case F/7.3mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set because the included gauges measure screws 5.41mm shorter than their actual length.

    Product
    Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2233-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling specific trauma guide wires because packaging defects may allow sterile barrier breaches, creating a potential risk of infection.

    Product
    BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2018·2018-06-27

    Pentax C2 CryoBalloon Focal Catheter Recalled for Connector Alignment Defect

    Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.

    Product
    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2018·2018-06-27

    Vascular Solutions Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins

    Vascular Solutions, Inc. is recalling specific lots of Drainer Centesis Catheters because the supplier reported a potential for unsafe levels of bacterial endotoxins.

    Product
    Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, creating a risk of infection.

    Product
    BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 248 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2018·2018-06-27

    Synthes Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Recalled

    Synthes (USA) Products LLC is recalling 7 units of a combined cannulated screw set because the included gauges measure screws 5.41mm shorter than actual length.

    Product
    Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2240-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 304 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2018·2018-06-27

    TriMed Nitinol Staples Recalled Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2235-2018·2018-06-27

    Zimmer Biomet Recalls Ball Tip Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 26 units of Ball Tip Guide Wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 361 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2018·2018-06-27

    TriMed Nitinol Staple Recall Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 1,194 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2264-2018·2018-06-27

    TriMed Recalls Nitinol Surgical Staples Due to Sterilization Record Gaps

    TriMed Inc. is recalling 706 units of Nitinol Surgical Staples because quarterly sterilization dose audits could not be verified, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2244-2018·2018-06-27

    Stryker Farabeuf Clamp Recalled for Incorrect Laser Etching on Lever Arm

    Stryker GmbH is recalling Farabeuf Clamps for 3.5mm Screws PRO because laser etching indicating compression or distraction mode is on the wrong side of the lever arm.

    Product
    Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2260-2018·2018-06-27

    BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

    Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

    Product
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2258-2018·2018-06-27

    BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

    Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

    Product
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2268-2018·2018-06-27

    Smith & Nephew Recalls Birmingham Hip Resurfacing Acetabular Cups for Labeling Defects

    Smith & Nephew is recalling six Birmingham Hip Resurfacing Acetabular Cups because they were distributed in the US with international labeling instead of FDA-approved instructions.

    Product
    Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2270-2018·2018-06-27

    Olympus JF-160F Duodenoscopes Recalled for New Reprocessing Procedures

    Olympus Corporation of the Americas is recalling 68 JF-160F duodenoscopes nationwide to implement validated new reprocessing procedures.

    Product
    Olympus JF-160F duodenoscopes (Model NumberJF-160F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0878-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object

    Dr. Reddy's Laboratories is recalling 6,397 bottles of Atorvastatin Calcium 80 mg tablets because a foreign object was found embedded in a tablet.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they failed impurities and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2259-2018·2018-06-27

    BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

    Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

    Product
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0888-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's Laboratories is recalling 130,081 bottles of Atorvastatin Calcium 40 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2261-2018·2018-06-27

    Paragon 28 Recalls P28 JAWS Nitinol Staple Kits Due to Missing Drill Guide

    Paragon 28, Inc. is recalling P28 JAWS Nitinol Staple System kits because the drill guide is missing from the package.

    Product
    P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2257-2018·2018-06-27

    Quantimetrix Recalls Dropper Plus Urinalysis Control Kits Due to Lot Error

    Quantimetrix Corporation is recalling 20 kits of Dropper Plus Point-of-Care Urinalysis Dipstick Control because they contained an incorrect lot of Level 1 vials.

    Product
    Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0887-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's Laboratories is recalling specific lots of Atorvastatin Calcium tablets because they failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2018·2018-06-26

    Aunt Kitty's Recalls Canned Chicken Gravy Due to Processing Deviation

    Aunt Kitty's Foods Inc. is recalling approximately 10,805 pounds of canned chicken gravy products due to a possible processing deviation that may have led to underprocessing.

    Product
    Aunt Kitty's Foods Inc — Aunt Kitty's Foods Inc. Recalls Canned Chicken Products Due to Possible Processing Deviation
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V432000·2018-06-26

    Lexus Recalls Vehicles for Fuel Leak Fire Risk

    Toyota is recalling specific Lexus models because fuel pulsation dampers may crack and leak, increasing the risk of a fire.

    Product
    LEXUS — LEXUS GS 350, IS 350, IS 350C, GS HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V433000·2018-06-26

    KME Predator Emergency Vehicles Recalled for Lifting Device Defect

    KME is recalling 13 Predator emergency vehicles because tip-mounted lifting devices do not meet safety load ratings, posing an injury risk.

    Product
    KME — KME PREDATOR, PREDATOR SS AERIAL, PREDATOR SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18181·2018-06-26

    Huish Outdoors Recalls Scuba Diving Regulators Due to Drowning Hazard

    Huish Outdoors is recalling Oceanic and Hollis scuba diving regulators because they can restrict airflow at low tank pressures, posing a drowning hazard to divers.

    Product
    Oceanic and Hollis scuba diving regulators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V430000·2018-06-25

    Audi Recalls 2013-2015 S8 and A8 Models for Fuel Leak Risk

    Volkswagen Group of America is recalling 2013-2015 Audi S8 and A8 vehicles because a fuel supply line may leak, increasing fire risk.

    Product
    AUDI — AUDI A8, S8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2018·2018-06-25

    People's Sausage Recalls Jerky and Meat Sticks Produced Without Inspection

    People's Sausage Co. is recalling approximately 13,554 pounds of jerky and meat stick products produced without an approved voluntary grant of inspection.

    Product
    People's Sausage Company, Inc. — People's Sausage Co. Recalls Jerky and Meat Stick Products Produced without an Approved Voluntary Grant of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18V424000·2018-06-25

    Spartan Emergency Vehicles Recalled for Fire Pump Solenoid Corrosion

    Spartan Motors is recalling 2009-2018 Gladiator and MetroStar emergency vehicles because internal corrosion in the fire water pump solenoid may cause loss of water pressure, increasing injury risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V429000·2018-06-25

    Keystone Recalls 2019 Summerland Trailers Due to Incorrect Tire Label

    Keystone is recalling 2019 Summerland recreational trailers because the Federal Identification Label lists an incorrect tire rim size, which could lead to improper rim replacement.

    Product
    KEYSTONE — KEYSTONE SUMMERLAND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·054-2018·2018-06-25

    Land O'Frost Recalls 4,944 Pounds of Misbranded Black Forest Ham

    Land O'Frost is recalling 4,944 pounds of Black Forest Ham because the back of the package incorrectly identifies the product as Honey Smoked Turkey Breast.

    Product
    Land O'Frost, Inc. — Recall Notification Report 054-2018 (Ham Products)
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·18V427000·2018-06-22

    Audi Recalls A4, A6, and RS4 Models Due to Air Bag Inflator Defect

    Volkswagen Group of America is recalling specific Audi models because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    AUDI — AUDI A4, A6, RS 4, RS4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·053-2018·2018-06-22

    Quay Corporation Recalls Pork Lard Produced Without Federal Inspection

    The Quay Corporation is recalling approximately 258,121 pounds of pork lard products produced without the benefit of federal inspection. The products were shipped to retail locations in Texas.

    Product
    The Quay Corporation — Quay Corporation Recalls Pork Products Produced Without Benefit Of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V422000·2018-06-21

    Triple E RV Recalls 2017-2018 Wonder Models Due to Wiring Defect

    Triple E RV is recalling 2017-2018 Wonder recreational vehicles because water can corrode wiring in the trailer tow module, potentially causing electrical shorts, fire, or crash risks.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V431000·2018-06-21

    BMW Recalls 2018 X3 Models for Rear Turn Signal Color Defect

    BMW is recalling 2018 X3 xDrive30i and M40i vehicles because rear turn signals may display incorrect colors, potentially confusing other drivers.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·052-2018·2018-06-21

    Agri Star Recalls Beef Pastrami Due to Processing Deviation

    Agri Star Meat and Poultry is recalling approximately 3,592 pounds of ready-to-eat beef pastrami due to possible underprocessing and inadequate curing.

    Product
    Agri Star Meat and Poultry, LLC — Agri Star Meat And Poultry LLC Recalls Beef Pastrami Products due to Possible Processing Deviation
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1546-2018·2018-06-20

    Pious Lion Pink Bali Product Recalled Due to Salmonella Contamination

    Pious Lion is recalling Pink Bali products in North Carolina and Tennessee after the North Carolina Dept. of Agriculture notified the firm that the product contains Salmonella.

    Product
    Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz plastic bag. 833-AVL-KRTM www.piouslion.com
    Category
    Food
    Distribution
    2 states
  • CriticalUSDA FSIS·051-2018·2018-06-20

    Texas Natural Meats Recalls Frozen Raw Ground Beef for E. coli O103

    Texas Natural Meats is recalling approximately 489 pounds of frozen raw ground beef products that may be contaminated with Shiga toxin-producing E. coli (STEC) O103.

    Product
    Texas Natural Meats — Texas Natural Meats Recalls Frozen Raw Ground Beef Products
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0875-2018·2018-06-20

    Allergan Recalls Taytulla Contraceptive Softgels Due to Out-of-Sequence Tablets

    Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.

    Product
    TAYTULLA — TAYTULLA (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1547-2018·2018-06-20

    Pious Lion Kratom Product Recalled Due to Salmonella Contamination

    Pious Lion is recalling 4 oz bags of White Maeng DA Kratom because the North Carolina Department of Agriculture found the product contains Salmonella.

    Product
    Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz plastic bag. 833-AVL-KRTM www.piouslion.com
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18E043000·2018-06-20

    TRW Air Bag Control Unit Recall for Hyundai and Kia Vehicles

    TRW is recalling air bag control units in certain Hyundai and Kia vehicles because electrical overstress may prevent air bags and seat belt pretensioners from deploying in a crash.

    Product
    AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2211-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 11 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M181578
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2152-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 350 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
    Category
    Medical Device
    Distribution
    2 states

Looking for a different month? Back to 2018.