The Recall Desk

Archive

June 2020 recalls

478 recalls were announced in June 2020.

What the numbers show

Critical
9
Severe
97
High
240
Moderate
118
Low
14

Of the 478 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

Which agencies issued them

401–478 of 478

  • HighFDA (Devices)·Z-2134-2020·2020-06-03

    Philips Recalls Sterilizable Defibrillator Internal Paddles Due to Wear Risk

    Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.

    Product
    Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2020·2020-06-03

    Nikon Metrology XTH Cabinet X-Ray Systems Recalled for Shielding Defect

    Nikon Metrology is recalling 110 XTH cabinet x-ray systems because interior shielding may detach, potentially causing x-ray emissions to exceed safety limits.

    Product
    Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Epump Safety Screw Spike sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2158-2020·2020-06-03

    Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Epix latis GRASPER devices because a protruding rivet may cause tissue damage during use.

    Product
    Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2131-2020·2020-06-03

    Intuitive Surgical Recalls da Vinci SP Cameras Due to Residual Soil

    Intuitive Surgical is recalling 305 da Vinci SP cameras because residual soil on the tip may affect image quality or cause patient sensitization.

    Product
    da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2020·2020-06-03

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 260 HeartStart MRx Monitor/Defibrillators because some units may not have received required corrections from prior field actions.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0961-2020·2020-06-03

    Absorb Health Joint Relief Recalled for Missing Shellfish Allergen Labeling

    Absorb Health LLC is recalling 70 bottles of Advanced Joint Relief capsules because the ingredient panel failed to list a shellfish allergen.

    Product
    Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES; Manufactured for: Absorb Health, 106 Countryside St NW, Supply, NC 28462 UPC 79056992863
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2155-2020·2020-06-03

    Biomet Recalls Vanguard M Partial Knee System MonoBlock Tibial Trays

    Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays due to potential elevated endotoxin levels.

    Product
    Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Safety Switch Delay

    Inpeco S.A. is recalling two Accelerator a3600 Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

    Product
    Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2161-2020·2020-06-03

    Applied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.

    Product
    Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2153-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.

    Product
    Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2020·2020-06-03

    Philips HeartStart XL Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.

    Product
    Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2020·2020-06-03

    Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels

    Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.

    Product
    Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Delayed Safety Switch Activation

    Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

    Product
    FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290)…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2102-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Connect ENPlus Spike Sets for Leaking

    Cardinal Health is recalling Kangaroo Connect ENPlus Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2143-2020·2020-06-03

    Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk

    Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.

    Product
    Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2020·2020-06-03

    Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels

    Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2020·2020-06-03

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures

    Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.

    Product
    ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2020·2020-06-03

    Radiometer ABL90 FLEX Analyzers Recalled for Hemolyzer Measurement Errors

    Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.

    Product
    ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2020·2020-06-03

    Siemens Cios Alpha X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.

    Product
    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2020·2020-06-03

    Biomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels

    Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.

    Product
    Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2020·2020-06-03

    Radiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors

    Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.

    Product
    ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2020·2020-06-03

    Cardinal Health Recalls Kangaroo 924 Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo 924 Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo 924 Safety Screw Spike Set, Product Code 775759
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0967-2020·2020-06-03

    Wegmans Tuna and Provolone Sub Recalled for Metal Contamination

    Wegmans is recalling Tuna & Provolone Packaged Subs because they may contain pieces of metal. Consumers should not eat the product.

    Product
    Wegmans Tuna & Provolone Packaged Sub, Medium, 11 oz; UPC: 2-27031-00000; SELL BY 5/14-5/16
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2159-2020·2020-06-03

    Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause damage during use.

    Product
    Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2132-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2020·2020-06-03

    Biomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns

    Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.

    Product
    Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0965-2020·2020-06-03

    Wegmans Tuna Salad Recalled for Potential Metal Contamination

    Wegmans Food Markets is recalling 958 units of Tuna Salad due to the potential presence of metal pieces.

    Product
    Wegmans Tuna Salad, 16 OZ (1 LB) 454 g; UPC: 77890-48147; SELL BY 5/21/20
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2100-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Joey Safety Screw Spike sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2133-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2020·2020-06-03

    MOTek Medical Recalls Body Weight Support Light Due to Yoke Detachment Risk

    MOTek Medical is recalling 80 units of the Body Weight Support Light (Model RB011) because a manufacturing deviation may cause the yoke to detach from the cable guide.

    Product
    Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Joey Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2149-2020·2020-06-03

    Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels

    Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2020·2020-06-03

    Biomet Recalls Shoulder Implant Components Due to Endotoxin Levels

    Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.

    Product
    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health Inc. is recalling Kangaroo Epump Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2152-2020·2020-06-03

    Biomet Recalls Vanguard Knee System Bearings Due to Endotoxin Levels

    Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2020·2020-06-03

    Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels

    Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2020·2020-06-03

    Abbott Recalls Architect iGentamicin Reagent Kits Due to Assay Interaction

    Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.

    Product
    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2020·2020-06-03

    Greiner VACUETTE Blood Transfer Units Recalled for Needle Dislodgement Risk

    C.A. Greiner & Sohne Gesellschaftmbh is recalling VACUETTE Blood Transfer Units because needles may dislodge during use, posing a risk of needle stick injury or blood leakage.

    Product
    VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2151-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specification limits.

    Product
    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0979-2020·2020-06-03

    Johnson Sea Products Recalls Home Style Crab Cakes for Undeclared Allergens

    Johnson Sea Products is recalling Home Style Crab Cakes because the packaging fails to list wheat and soybean oil as ingredients.

    Product
    Home Style Crab Cakes in a plastic wrapped foam tray, 12 oz. (Four, 3 oz. crab cakes per package). 12 packages per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2109-2020·2020-06-03

    Argon Skater Introducer Set Recalled Due to Detaching Tungsten Coils

    Argon Medical Devices is recalling Skater Introducer Sets because tungsten coils on the guidewire may detach. The recall affects 15,795 units distributed in China and Taiwan.

    Product
    Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2163-2020·2020-06-03

    Hologic Panther Fusion Extraction Reagent-S Recalled for False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-S kits because a reagent component may cause false positive or negative flu test results, potentially delaying treatment.

    Product
    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-0968-2020·2020-06-03

    Wegmans Tuna and Provolone Wheat Wrap Recalled for Metal Contamination

    Wegmans is recalling 958 units of Tuna & Provolone Wheat Wraps because they may contain pieces of metal. Consumers should not eat the product.

    Product
    Wegmans Packaged Tuna & Provolone Wheat Wrap, 9 oz; UPC: 2-27303-00000; SELL BY 5/14-5/16
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2110-2020·2020-06-03

    Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error

    The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.

    Product
    Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2141-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2020·2020-06-03

    Siemens ARTIS Pheno X-Ray Systems Recalled for Drivetrain Faults

    Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.

    Product
    ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2106-2020·2020-06-03

    Medtronic Guardian Connect App iOS Recall for Battery Life Issues

    Medtronic is recalling the Guardian Connect App for iOS due to shortened transmitter battery life on specific iPhone, iPad, and iPod Touch devices.

    Product
    Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2020·2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2020·2020-06-03

    Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

    Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.

    Product
    Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2020·2020-06-03

    PD-Rx Recalls Doxycycline Hyclate Tablets for Failed Dissolution Specifications

    PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The recall covers 14,030 bottles distributed nationwide.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2020·2020-06-03

    Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

    Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing sterility.

    Product
    Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing 41 units of spinal cord stimulation lead extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1278-2020·2020-06-03

    LidoPro Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling LidoPro patches because manufacturing records and samples were lost, preventing verification of product stability.

    Product
    LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1277-2020·2020-06-03

    LidoPatch Pain Relief Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling LidoPatch pain relief patches because missing manufacturing records prevent verification that the product remains within specification through its expiration date.

    Product
    LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0959-2020·2020-06-03

    Siete Grain Free Cashew Flour Tortillas Recalled for Foreign Material

    Garza Food Ventures is recalling Siete Grain Free Cashew Flour Tortillas due to a potential to contain foreign material.

    Product
    Siete Grain Free Cashew Flour Tortillas NET WT 7 OZ (200g) 8 Count UPC 865336000045 packaged in flexible plastic
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1279-2020·2020-06-03

    Mencaine Lidocaine Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling Mencaine patches because manufacturing records and samples were lost, preventing verification that the product remains within specification through expiration.

    Product
    Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0962-2020·2020-06-03

    Jindilli Beverages Recalls Milkadamia Unsalted Buttery Spread for Potential Mold

    Jindilli Beverages LLC is recalling Milkadamia Unsalted Buttery Spread due to the potential to contain mold. The product was distributed nationwide.

    Product
    Milkadamia Unsalted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004725
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2020·2020-06-03

    GE Healthcare Recalls Giraffe Shuttle Upgrade Kits Due to Battery Odor

    GE Healthcare is recalling Giraffe Shuttle upgrade kits because the batteries emit a strong sulfur odor during charging.

    Product
    Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0963-2020·2020-06-03

    Jindilli Beverages Recalls Milkadamia Salted Buttery Spread for Potential Mold

    Jindilli Beverages LLC is recalling 2,981 cases of Milkadamia Salted Buttery Spread due to the potential presence of mold.

    Product
    Milkadamia Salted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004718
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1280-2020·2020-06-03

    CVS Lidocaine Cold and Hot Patch Recalled for Manufacturing Record Loss

    CVS Pharmacy is recalling Maximum Strength Lidocaine Cold & Hot Patches because manufacturing records and samples were lost, meaning the product may not remain within specification through its expiration date.

    Product
    Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1274-2020·2020-06-03

    West-Ward Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure

    West-Ward Columbus Inc. is recalling Doxycycline Hyclate 100 mg tablets because they failed a dissolution test at the end of their shelf life.

    Product
    DOXYCYCLINE HYCLATE — DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2140-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

    Product
    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2122-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2121-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1281-2020·2020-06-03

    Lamotrigine Tablets Recalled for Presence of Foreign Silica Granules

    Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, 150 mg, due to the presence of foreign silica granules consistent with desiccant pack material.

    Product
    Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2119-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1)…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2120-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Extension Kits Due to Labeling Error

    Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.

    Product
    Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2123-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Adapters Due to Labeling Error

    Boston Scientific is voluntarily removing two Precision M8 Adapters because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2125-2020·2020-06-03

    Boston Scientific Recalls Deep Brain Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to…
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·20V320000·2020-06-01

    Keystone Recalls 2020 Springdale Trailers Due to Incorrect Axles and Tires

    Keystone RV Company is recalling 2020 Springdale trailers because they were equipped with incorrect axles and tires, which may cause the trailer to be overloaded and increase the risk of a crash.

    Product
    KEYSTONE — KEYSTONE SPRINGDALE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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