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.

Which agencies issued them

501–577 of 577

  • HighFDA (Devices)·Z-2032-2018·2018-06-06

    Arrow International Recalls 9 Fr. Radiopaque Polyurethane Sheath Due to Packaging Defect

    Arrow International Inc is recalling 416,055 units of 9 Fr. Radiopaque Polyurethane Sheath/Dilator because unsealed packaging may compromise product sterility.

    Product
    9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2018·2018-06-06

    Arrow PICC Set Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 ARROW PICC Sets because unsealed packaging may compromise product sterility.

    Product
    ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2018·2018-06-06

    Arrow Arterial Line Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise

    Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Code: ASK-04000-HMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2018·2018-06-06

    Arrow Maximal Barrier Drapes Recalled for Potential Sterility Compromise

    Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00376-SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1569-2018·2018-06-06

    Dawn's Fresh Foods Recalls Finest Traditions Deluxe Potato Salad

    Morski Brands Inc. is recalling Finest Traditions Deluxe Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Finest Traditions Deluxe Potato Salad, Packaged into the following sized containers: 1. Net Wt. 1 lb. (16 oz.)(454g), UPC 33147-00007. Shipping Case: (6-1 lbs) Net Wt. 6 lbs. (2.72kg) Item number 1038768, Mfg. No. 11013, 2. Net Wt. 8 lbs. (3.63kg), Item Number 103856
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1954-2018·2018-06-06

    Draeger Carina Ventilator Recalled Due to Valve Assembly Corrosion Risk

    Draeger Medical is recalling eight Carina Ventilators because valve assembly corrosion may contaminate breathing gas.

    Product
    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1497-2018·2018-06-06

    Hickory Harvest Island Fruit Mix Recalled for Listeria Risk

    Ohio Hickory Harvest Brand Products Inc. is recalling Hickory Harvest Island Fruit Mix due to Listeria monocytogenes found in a product stored in the same bin.

    Product
    Hickory Harvest Island Fruit Mix NET WT 9 oz (255g) Distributed by: Hickory Harvest Foods, Akron, OH 44319 UPC 0-36232-06052-9
    Category
    Food
    Distribution
    33 states
  • HighNHTSA·18V377000·2018-06-06

    Spartan Recalls Utilimaster Vans for Missing Seat Belt Retractors

    Spartan Motors is recalling 1991-2018 Utilimaster Aeromaster and Walk-In Vans because front seat belts lack required retractors, increasing crash injury risk.

    Product
    UTILIMASTER — UTILIMASTER AEROMASTER, WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18746·2018-06-06

    Vernier Circuit Board 2 Recalled Due to Burn Hazard

    Vernier Software & Technology is recalling Circuit Board 2 units because overheating switches can cause burns. About 4,200 units were sold between 2015 and 2018.

    Product
    Vernier Circuit Board 2
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1495-2018·2018-06-06

    Ziyad Brand Tahini Recalled for Potential Salmonella Contamination

    Ziyad Brothers Importing is voluntarily recalling Ziyad Brand Tahini in various glass jar sizes due to potential Salmonella contamination.

    Product
    Ziyad Brand Tahini, 8oz, 16oz, ¿ gal, 32oz. , packed in glass jars
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-1953-2018·2018-06-06

    Genesee BioMedical Sternal Valve Retractors Recalled for Corrosion-Related Blade Failure

    Genesee BioMedical is recalling 444 Sternal Valve Retractors used in cardiac surgery due to corrosion that may cause the bearing or button to break.

    Product
    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2018·2018-06-06

    Medline Needle Counters Recalled Due to Packaging Seal Creep

    Medline Industries Inc is recalling MEDLINE O.R. Necessities Sterile Needle Counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2018·2018-06-06

    Arrow International Recalls Maximal Barrier Drapes Due to Packaging Defect

    Arrow International is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall covers lots distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Code: ASK-01000-UPMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2018·2018-06-06

    NordicNeuroLab Recalls nordicICE 2.3.14 Image Processing Software

    NordicNeuroLab AS is recalling 97 licenses of nordicICE 2.3.14 image processing software due to a defect that may cause incorrect orientation labeling and image flipping.

    Product
    nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1903-2018·2018-06-06

    Heartware Medtronic HVAD System Recalled for Transient Electrical Interruptions

    Heartware is recalling HVAD System components due to possible transient electrical connection interruptions that may cause unexpected beeping or power switching.

    Product
    Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2018·2018-06-06

    Syva EMIT 2000 Theophylline Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling Lot J1 of the Syva EMIT 2000 Theophylline Assay because it may show increased imprecision when used with a Beckman AU Clinical Chemistry System.

    Product
    Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2018·2018-06-06

    Arrow International Recalls Catheter Hemostasis Valves Due to Packaging Defect

    Arrow International is recalling 416,055 catheter hemostasis valves because unsealed packaging may compromise product sterility.

    Product
    Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1943-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Cords Due to Seal Risk

    Olsen Medical is recalling 71,890 Symmetry monopolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Des
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1933-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1990-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 central venous catheter kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1944-2018·2018-06-06

    Olsen Medical Recalls Bipolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling specific Symmetry Olsen bipolar forceps because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1940-2018·2018-06-06

    Siemens SOMATOM Go.Up CT Scanner Recalled for Software Issue

    Siemens is recalling 33 SOMATOM Go.Up CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2040-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Devices

    Torax Medical is recalling LINX Reflux Management Systems because a bead component may separate from an adjacent wire link, potentially resulting in a discontinuous or open device.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Lapa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1972-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1936-2018·2018-06-06

    Medline Needle Counters Recalled for Potential Packaging Seal Creep

    Medline Industries is recalling 2,600 units of sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2018·2018-06-06

    Arrow International Recalls CVC Kits Due to Unsealed Packaging

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Pencil Devices Due to Seal Risk

    Olsen Medical is recalling 665,350 Symmetry Monopolar Pencil devices because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1998-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International Inc is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Access Kits

    Arrow International Inc. is recalling 416,055 Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2018·2018-06-06

    Dynarex Oxygen Regulator Recalled for Inaccurate Flow Rate Indicator

    Dynarex Corporation is recalling 15 CGA870 oxygen regulators because the dial has an inaccurate flow rate indicator. The devices were distributed in Massachusetts and New Jersey.

    Product
    Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical ga
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1995-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2018·2018-06-06

    Arrow Radial Arterial Access Kits Recalled for Unsealed Packaging

    Arrow International is recalling Radial Arterial Access Kits because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Radial Arterial Access Kit; Product Code: ASK-04001-BID2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2018·2018-06-06

    Arrow International Recalls Echogenic Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 echogenic needles because unsealed packaging may compromise product sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    Echogenic Needle; Product codes: PN-00215-E and PN-00217-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00002-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2014-2018·2018-06-06

    Arrow-Johans ECG Adapter Recalled for Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ECG adapters because unsealed packaging may compromise product sterility.

    Product
    Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2018·2018-06-06

    NordicNeuroLab Recalls nordicBrainEX Software Due to Fiber Tract Alignment Error

    NordicNeuroLab AS is recalling 36 licenses of nordicBrainEX version 1.1.2 because a software error can cause fiber tracts to be misaligned when switching between image series with identical resolutions.

    Product
    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2007-2018·2018-06-06

    Arrow International Recalls 5Fr Catheter Clamps Due to Sterility Concerns

    Arrow International is recalling 5Fr Catheter Clamps with Fasteners because unsealed packaging may compromise product sterility.

    Product
    5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1999-2018·2018-06-06

    Arrow International Recalls Central Venous Catheterization Kits Due to Packaging Issues

    Arrow International Inc. is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1961-2018·2018-06-06

    Arrow International Recalls Epidural Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 epidural needles because unsealed packaging may compromise product sterility. The recall covers distribution in the US and 35 other countries.

    Product
    Epidural Needle; Product Codes: AN-05501 and AN-05505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1939-2018·2018-06-06

    Siemens SOMATOM go.Now CT Scanner Software Recall

    Siemens Medical Solutions is recalling 4 SOMATOM go.Now CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2018·2018-06-06

    Joerns Healthcare Recalls P.R.O. Matt and ProCair Mattresses Due to Connector Defect

    Joerns Healthcare is recalling 915 P.R.O. Matt and ProCair Mattresses because incorrect connectors were supplied, lacking internal shutoff valves required to prevent air loss.

    Product
    P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1935-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline Industries is recalling sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2017-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1976-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Issues

    Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2018·2018-06-06

    Olsen Medical Recalls Bipolar Cords Due to Sterile Seal Risk

    Olsen Medical is recalling 323,886 bipolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2034-2018·2018-06-06

    Joerns Healthcare Recalls ProCair Mattresses Due to Missing Air Shutoff Valves

    Joerns Healthcare is recalling specific ProCair and P.R.O. Matt mattresses because they were supplied with connectors lacking required internal shutoff valves, which can cause air to escape from the mattress cells.

    Product
    ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent dec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling specific central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0836-2018·2018-06-06

    Lupin Recalls Hydrocodone and Acetaminophen Tablets for Missing Labels

    Lupin Pharmaceuticals is recalling 1,672 bottles of Hydrocodone Bitartrate and Acetaminophen tablets in Ohio due to missing labels.

    Product
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN — HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    1 state
  • HighCPSC·18172·2018-06-05

    Keyera Energy Recalls Propane Gas Due to Fire and Explosion Hazards

    Keyera Energy is recalling under-odorized propane gas in Texas and Louisiana due to fire and explosion risks. Consumers should contact suppliers for a free inspection.

    Product
    Propane (LP) gas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V372000·2018-06-05

    Manac Recalls Steel Flatbed and Dropdeck Trailers Due to Lashing Chain Defect

    Manac is recalling 2013-2018 Steel Dropdeck, 2017 Extendable Steel Dropdeck, and 2018 Steel Flatbed trailers because lashing chains may break, allowing cargo to slide or tip.

    Product
    MANAC — MANAC STEEL DROPDECK, EXTENDABLE STEEL DROPDECK, STEEL FLATBED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·045-2018·2018-06-04

    Goodman Recalls Fully Cooked Ground Beef Due to Plastic Contamination

    Goodman Food Products is recalling approximately 34,400 pounds of fully cooked ground beef products due to possible contamination with hard, white plastic.

    Product
    Goodman Food Products, Texas Inc. — Goodman Food Products Recalls Fully Cooked Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·18V370000·2018-06-04

    Audi Recalls A6, A7, S6, S7, RS 7 for Air Bag Sensor Defect

    Volkswagen Group of America is recalling 139,249 Audi vehicles because a faulty seat sensor may prevent the front passenger air bag from deploying in a crash.

    Product
    AUDI — AUDI A6, A7, RS 7, S6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V361000·2018-06-01

    Forest River Recalls 2019 Wildcat Trailers Due to Underrated Tires

    Forest River is recalling 2019 Wildcat recreational trailers because they were equipped with underrated tires, which could lead to tire failure and increase the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER WILDCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V369000·2018-06-01

    Volkswagen and Audi Recall 2018 Models for Brake Caliper Coating Defect

    Volkswagen and Audi are recalling 2018 models because brake caliper pistons may have insufficient coating, potentially reducing braking performance and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI PASSAT, GTI, GOLF, SQ5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V364000·2018-06-01

    Jayco Recalls 2018-2019 Fifth-Wheel Trailers Due to Propane Strap Defect

    Jayco is recalling 2018-2019 fifth-wheel trailers because the propane tank strap may separate, increasing the risk of a crash or fire.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO TRAVEL TRAILER, JAYCO NORTH POINT, PINNACLE, SEISMIC, EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V366000·2018-06-01

    Forest River Recalls Transit Buses Due to Rear Axle U-Bolt Defect

    Forest River is recalling certain 2018-2019 transit buses because insufficiently tightened rear axle U-bolts may break, causing the axle to separate and increasing crash risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, FOREST RIVER, ELKHART SENATOR II MVP, ALLSTAR MVP, SENATOR II, ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V363000·2018-06-01

    Kia Recalls 507,587 Vehicles Due to Air Bag Control Unit Short Circuit Risk

    Kia is recalling 507,587 vehicles because the air bag control unit may short circuit, preventing frontal air bags and seat belt pretensioners from deploying in a crash.

    Product
    KIA — KIA FORTE, SEDONA, OPTIMA, OPTIMA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V367000·2018-06-01

    MORryde Recalls 2018 Ford E-450 Chassis Due to Loose U-Bolts

    MORryde is recalling 2018 Ford E-450 chassis modified for transit bus use because insufficiently tightened U-bolts may allow the rear axle to separate, increasing crash risk.

    Product
    FORD — FORD E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V362000·2018-06-01

    Starcraft Telluride Fifth-Wheel Trailer Propane Strap Recall

    Starcraft is recalling 2019 Telluride fifth-wheel trailers because the propane tank strap may separate, increasing the risk of a crash or fire.

    Product
    STARCRAFT RV FW — STARCRAFT RV FW TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V357000·2018-06-01

    2019 Forest River and Coachmen Motorhomes Recalled for Rear Axle Defect

    Forest River is recalling 2019 Forester, Sunseeker, and Coachmen Leprechaun and Freelander motorhomes because rear axle U-Bolts may loosen, increasing crash risk.

    Product
    COACHMEN — COACHMEN, FOREST RIVER LEPRECHAUN, SUNSEEKER, FORESTER, FREELANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide

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