The Recall Desk

Archive

May 2020 recalls

456 recalls were announced in May 2020.

What the numbers show

Critical
3
Severe
100
High
239
Moderate
97
Low
17

Of the 456 recalls this month scored against our rubric, 1% are Critical, 22% are Severe.

Which agencies issued them

201–300 of 456

  • HighFDA (Devices)·Z-1979-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V288000·2020-05-20

    Vac-Tron Vacuum Excavator Trailers Recalled for Lighting and Reflectivity Defects

    Vac-Tron is recalling 2016-2020 vacuum excavator trailers because improper lamp positioning and missing reflectors may reduce visibility and increase crash risk.

    Product
    VAC-TRON — VAC-TRON LP MINI 373 GT, LP MINI 373 DT, CS 870 GT, CS 873 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 110 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2020·2020-05-20

    Cardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V290000·2020-05-20

    Vac-Tron Vacuum Excavator Trailers Recalled for Lighting Defects

    Vac-Tron is recalling 2016-2020 vacuum excavator trailers because front clearance lamps may be positioned improperly and reflectors may be missing, increasing crash risk.

    Product
    VAC-TRON — VAC-TRON LP 1273 XDT, CS 1270 GT, CS 1273 GT, CS 870 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling 110,350 Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2020·2020-05-20

    Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error

    Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.

    Product
    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2020·2020-05-20

    Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits

    Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.

    Product
    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1963-2020·2020-05-20

    DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes

    DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.

    Product
    DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e.…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1998-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1964-2020·2020-05-20

    Bard PowerPort ClearVUE Slim Implantable Port Recalled for Incorrect Catheter Lock Size

    Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.

    Product
    BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1999-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1928-2020·2020-05-20

    Edwards HemoSphere Oximetry Cable Recalled for Inconsistent Connector Crimping

    Edwards Lifesciences is recalling 35 HemoSphere oximetry cables due to intermittent communication caused by inconsistent crimping of connectors.

    Product
    Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0940-2020·2020-05-20

    Natural by Nature 1% Milk Recalled for Antibiotic Residue

    Natural Dairy Products is recalling Natural by Nature 1% Milk due to a sample testing positive for antibiotic residue. The product was distributed to seven states.

    Product
    Natural by Nature 1 % Milk (gallon, 1/2 gallon, and quart)
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1942-2020·2020-05-20

    Karl Storz Endoscopy Recalls Insufflation Tubing Due to Ethylene Oxide Residues

    Karl Storz Endoscopy is recalling sterile insufflation tubing because it may contain higher ethylene oxide residues than the acceptable level.

    Product
    Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1970-2020·2020-05-20

    C.R. Bard Recalls SureStep Foley Tray Systems Due to Residue

    C.R. Bard is recalling 8,392 SureStep Foley Tray Systems because a white paper-type residue may be attached to the catheter.

    Product
    SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2002-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2000-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2001-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1971-2020·2020-05-20

    BD Biosciences Recalls CD45 Reagent Due to False Positive Reactions

    Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.

    Product
    Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2020·2020-05-20

    Gore DrySeal Flex Introducer Sheath Recalled for Incorrect Size Labeling

    W. L. Gore & Associates is recalling 141 Gore DrySeal Flex Introducer Sheaths because 16Fr devices were mislabeled as 14Fr.

    Product
    Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1262-2020·2020-05-20

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures

    The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Food)·F-0943-2020·2020-05-20

    Dole Classic Kit Light Caesar Salad Recalled for Low Chlorine Wash

    Dole Fresh Vegetables Inc is recalling Classic Kit Light Caesar salad kits due to a critical control point deviation involving low levels of chlorine in the wash process.

    Product
    Dole "Classic Kit Light Cesar" fresh salad mix. Salad and topping Net Wt.7.7 OZ (218g), Dressing Net 2.2 FL OZ (65ml), Total Net Wt. 10 OZ (283g), Thoroughly Washed, Perishable/Keep Refrigerated.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1997-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1996-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2006-2020·2020-05-20

    Ra Medical Systems Recalls DABRA Catheters Due to Calibration Failure Risk

    Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.

    Product
    Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2020·2020-05-20

    Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions

    Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.

    Product
    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2005-2020·2020-05-20

    Genicon EZee Specimen Retrieval Bag Recall for Labeling Clarity

    Genicon is recalling 1,550 units of the EZee Single Use Specimen Retrieval Bag to provide updated labeling instructions for multiple specimen retrieval.

    Product
    Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling five TandemHeart pump kits because an assembly error may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0944-2020·2020-05-20

    Dole Recalls Hearts of Romaine Due to Low Chlorine Wash Levels

    Dole Fresh Vegetables Inc is recalling Hearts of Romaine because a critical control point deviation resulted in low levels of chlorine during the wash process.

    Product
    Hearts of Romaine. Product is fresh and packaged in 9 ounce (255g) plastic bags.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1931-2020·2020-05-20

    Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions

    Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.

    Product
    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2020·2020-05-20

    Medtronic Recalls Vertex Select Multi Axial Screws Due to Length Discrepancy

    Medtronic is recalling 83 Vertex Select Multi Axial Screws because the product length is shorter than labeled. The recall covers units distributed in California and Michigan.

    Product
    VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2020·2020-05-20

    Becton Dickinson Recalls PowerGlide ST Midline Catheter Kits Missing Lidocaine

    Becton Dickinson is recalling 655 PowerGlide ST Midline Catheter Maximal Barrier Kits because they were packaged without the required lidocaine.

    Product
    PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Drugs)·D-1267-2020·2020-05-20

    ChapStick Total Hydration Moisture Tint Recalled for Packaging Separation

    Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Very Berry due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT VERY BERRY — CHAPSTICK TOTAL HYDRATION MOISTURE TINT VERY BERRY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1268-2020·2020-05-20

    ChapStick Total Hydration Moisture Tint Recalled for Packaging Separation

    Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Pretty in Pink due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT PRETTY IN PINK — CHAPSTICK TOTAL HYDRATION MOISTURE TINT PRETTY IN PINK (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1266-2020·2020-05-20

    ChapStick Lip Balm Recalled for Packaging Separation

    Glaxosmithkline is recalling 288 packages of ChapStick Total Hydration Moisture Tint Peachy Keen due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT PEACHY KEEN — CHAPSTICK TOTAL HYDRATION MOISTURE TINT PEACHY KEEN (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V282000·2020-05-19

    Altec Recalls Aerial Devices and Digger Derricks Due to Bolt Failure Risk

    Altec is recalling 2018-2020 aerial devices and digger derricks because bolts securing the pedestal to the turntable may fail, increasing the risk of injury or death.

    Product
    ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V279000·2020-05-18

    Mitsubishi Recalls Lancer and Outlander Models for Corroded Front Cross Members

    Mitsubishi is recalling specific Lancer, Outlander, and Outlander Sport vehicles because front cross members may corrode and detach, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI LANCER, OUTLANDER, OUTLANDER SPORT, LANCER SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V281000·2020-05-18

    Western Star 4700 and 5700 trucks recalled for ground harness wiring defect

    DTNA is recalling certain 2019-2021 Western Star 4700 and 5700 trucks. An undersized wire in the ground harness may cause a melted connector, leading to engine stall and increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR 4700, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V280000·2020-05-18

    Mitsubishi Recalls Outlander Models Due to Second-Row Seat Belt Assembly Defect

    Mitsubishi is recalling 2019-2020 Outlander and 2019 Outlander PHEV vehicles because the right-side second-row seat belt may be assembled incorrectly, potentially failing to restrain occupants in a crash.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V277000·2020-05-15

    Yamaha Recalls 2015-2018 XC155 Scooters Due to Cylinder Head Nut Issue

    Yamaha is recalling 2015-2018 XC155 scooters because cylinder head nuts may loosen, causing coolant to foul the spark plug and potentially leading to engine stalling.

    Product
    YAMAHA — YAMAHA SMAX, XC155F
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20122·2020-05-14

    Garia Recalls Electric Golf and Courtesy Vehicles Due to Fire Hazard

    Garia is recalling about 1,000 battery-powered golf and courtesy vehicles because a fuse can overheat and melt while charging, posing a fire hazard.

    Product
    Garia Golf & Courtesy battery-powered electric vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20744·2020-05-14

    John Deere Recalls Broom Attachment Kits Due to Missing Manual

    John Deere is recalling 60-inch broom attachment kits for compact utility tractors because they lack the required Operator's Manual, posing an injury hazard.

    Product
    Attachment Kits for John Deere 60-inch Brooms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20743·2020-05-14

    Jade Bloom Essential Oils Recalled for Non-Child-Resistant Packaging

    W8 Distributing is recalling Jade Bloom Wintergreen and Birch Sweet Essential Oils because the packaging is not child-resistant, posing a poisoning risk to young children.

    Product
    Jade Bloom Wintergreen and Birch Sweet Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V275000·2020-05-14

    Heartland Recalls 2020 Trailers Due to Spare Tire Carrier Defect

    Heartland is recalling 2020 Trail Runner, Wilderness, Mallard, and Prowler trailers because a U-bolt on the spare tire carrier may break, causing the tire to detach.

    Product
    HEARTLAND — HEARTLAND WILDERNESS, MALLARD, TRAIL RUNNER, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20745·2020-05-14

    Organic Pure Oil Recalls Wintergreen Essential Oil for Packaging Defect

    Organic Pure Oil is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Organic Pure Oil Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20123·2020-05-14

    Sterno Home Recalls Path Light Kits Due to Electric Shock Hazard

    Sterno Home is recalling Hampton Bay, Patriot, and Paradise path light kits because a defective power supply poses an electric shock risk.

    Product
    Hampton Bay, Patriot Lighting and Paradise light kits with Sterno Home LED power supplies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1847-2020·2020-05-13

    Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.

    Product
    Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1846-2020·2020-05-13

    Applied Medical Recalls Python Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Python Embolectomy Catheters because the tips may separate during use, posing a risk of unintended dislodgement in patients.

    Product
    Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2020·2020-05-13

    Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations

    Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.

    Product
    Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Food)·F-0938-2020·2020-05-13

    Medifast Recalls Optavia Oatmeal Pouches Due to Undeclared Milk

    Medifast is recalling Optavia Old Fashioned Maple & Brown Sugar Oatmeal pouches because they contain undeclared milk.

    Product
    Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer Kraft paper/aluminum pouches, Seven pouches per carton
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1791-2020·2020-05-13

    Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation

    Argon Medical Devices is recalling specific 0.035-inch guidewires because the stiffness of the soft end caused tissue perforation. The affected units were distributed to several countries outside the United States.

    Product
    0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0937-2020·2020-05-13

    Tainy Boctoka Dry Fruits Mix Recalled for Undeclared Sulfites

    Royal International Trading Inc. is recalling Tainy Boctoka Dry Fruits Mix because the product contains undeclared sulfites.

    Product
    TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE; Assorted dried fruits; NET WT 17.63 oz (500g) clear plastic package
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1843-2020·2020-05-13

    Philips TEE Transducers Recalled Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.

    Product
    REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1863-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2020·2020-05-13

    Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation Risk

    Argon Medical Devices is recalling specific 0.035-inch guidewires because the soft tip stiffness caused tissue perforation. The affected units were distributed to several countries outside the US.

    Product
    0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1920-2020·2020-05-13

    ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error

    ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.

    Product
    REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1848-2020·2020-05-13

    Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation

    Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.

    Product
    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1911-2020·2020-05-13

    ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.

    Product
    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1912-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1913-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
    Category
    Medical Device
    Distribution
    44 states
  • SevereNHTSA·20V274000·2020-05-13

    Audi Recalls 2020 A6, A7, and Allroad for Airbag Deployment Defect

    Volkswagen Group of America is recalling 2020 Audi A6, A7, and Allroad vehicles because the passenger airbag may not deploy properly, increasing injury risk.

    Product
    AUDI — AUDI ALLROAD, A6, A7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1865-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V270000·2020-05-13

    Porsche Recalls 2019-2020 Cayenne Models Due to Fuel Line Leak Risk

    Porsche is recalling 2,253 Cayenne vehicles because a fuel line connector may leak, increasing the risk of fire.

    Product
    PORSCHE — PORSCHE CAYENNE TURBO S HYB COUPE, CAYENNE S E-HYBRID, CAYENNE TURBO, CAYENNE TURBO COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2020·2020-05-13

    Siemens AXIOM Aristos FX Plus X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 399 AXIOM Aristos FX Plus x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1896-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci Xi Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.

    Product
    da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 9 units of IPS e.max ZirCAD CER/inLab LT A1 C17/5 ceramic blocks because they crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 215 Snappy Abutment 5.5 CC RP 3 mm units because they may contain incorrect screws that could loosen.

    Product
    Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci X Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulators for da Vinci X systems due to high friction causing arm movement issues.

    Product
    da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 650 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-0932-2020·2020-05-13

    Aldi Recalls Organic Red Split Lentils for Undeclared Wheat

    Aldi is recalling Simply Nature Organic Red Split Lentils because the product may contain undeclared wheat. This poses a risk to individuals with wheat allergies or celiac disease.

    Product
    Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 041498299507
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1921-2020·2020-05-13

    Philips Brilliance iCT Computed Tomography Systems Recalled for Bolt Defect

    Philips North America, LLC is recalling 19 Brilliance iCT Computed Tomography X-Ray Systems because a bolt affixing the cooling unit to the rotor was not tightened to specification.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1875-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0951-2020·2020-05-13

    Benefiber Prebiotic Fiber Supplement Recalled for Potential Plastic Contamination

    Glaxosmithkline is recalling specific lots of Benefiber Prebiotic Fiber Supplement because the product may contain small plastic pieces.

    Product
    Benefiber Prebiotic Fiber Supplement, packaged in the following ways 1) Net Wt. 500 g (17.6 oz) bottle. UPC 886790218302 and 2) Net Wt. 760 g bottle UPC 8886790211907
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1866-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2020·2020-05-13

    Delfi VariFit Contour Cuffs Recalled for Inadequate Weld

    Delfi Medical Innovations is recalling 59 units of VariFit Contour Cuffs due to a manufacturing defect that may cause the cuff to leak.

    Product
    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1885-2020·2020-05-13

    Northgate Technologies Recalls ACMI 9FR Probes Due to Biocompatibility Failure

    Northgate Technologies is recalling ACMI 9FR probes used for stone fragmentation because a lot failed biocompatibility testing.

    Product
    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2020·2020-05-13

    Northgate Technologies Recalls Autolith Uro-Tch 9FR Probes for Biocompatibility Failure

    Northgate Technologies is recalling Autolith Uro-Tch 9FR probes because a lot failed biocompatibility testing. The recall covers 198 boxes distributed nationwide.

    Product
    AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at the seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V271000·2020-05-13

    Porsche Recalls 2020 Cayenne for Transmission Oil Pipe Weld Defect

    Porsche is recalling 2020 Cayenne vehicles because an insufficient weld on a transmission oil pipe may cause fluid leaks, potentially making roads slippery and increasing crash risk.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2020·2020-05-13

    Philips S8-3t Transesophageal Ultrasound Transducers Recalled for Temperature Measurement Failure

    Philips is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 350 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1925-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Due to Unsealed Pouches

    Stryker is recalling 26,298 units of Spy-Phi Drapes and Packs because sterile drapes were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0931-2020·2020-05-13

    Aldi Recalls Simply Nature Organic Green Lentils for Undeclared Wheat

    Aldi Inc is recalling Simply Nature Organic Green Lentils because the product may contain undeclared wheat, posing a risk to individuals with wheat allergies.

    Product
    Simply Nature Organic Green Lentils, 16 oz bag, UPC 041498299514
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2020·2020-05-13

    Ivoclar Vivadent Recalls Dental Ceramic Blocks Due to Cracking During Sintering

    Ivoclar Vivadent AG is recalling specific lots of IPS e.max ZirCAD CER/inLab Start.Kit LT dental ceramic blocks because they may crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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