The Recall Desk

Archive

June 2020 recalls

478 recalls were announced in June 2020.

What the numbers show

Critical
9
Severe
88
High
249
Moderate
118
Low
14

Of the 478 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

101–200 of 478

  • SevereUSDA FSIS·013-2020·2020-06-17

    La Bodega Meat LLC Recalls Raw Beef Products Lacking Import Re-Inspection

    La Bodega Meat LLC is recalling approximately 83,038 pounds of raw beef products that were distributed without the benefit of import re-inspection.

    Product
    La Bodega Meat LLC Recalls Beef Products Distributed Without Benefit of Import Re-Inspection
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2349-2020·2020-06-17

    RayStation 9A Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.

    Product
    RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2342-2020·2020-06-17

    RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.

    Product
    RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2348-2020·2020-06-17

    RayStation 8B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 8B Service Pack 2 software due to a defect in dose calculation algorithms that could underestimate radiation dose.

    Product
    RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2330-2020·2020-06-17

    Medtronic Mazor X Surgical System Positioner Recalled for Detachment Risk

    Medtronic is recalling 177 Mazor X Surgical System Positioner Type II units because they may unexpectedly detach from the operating table, posing a risk of blunt injury to patients.

    Product
    Mazor X Surgical System Positioner Type II, REF: ASM0214-02
    Category
    Medical Device
    Distribution
    28 states
  • SevereCPSC·20138·2020-06-17

    Rexair Recalls Rainbow SRX Vacuums Due to Fire and Burn Hazards

    Rexair is recalling about 38,000 Rainbow SRX vacuums because the circuit board can spark, posing fire and burn hazards. Two fires have been reported.

    Product
    Rainbow SRX Vacuums
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1302-2020·2020-06-17

    QuVa Pharma Recalls Subpotent Oxytocin Injection Bags

    QuVa Pharma is recalling 648 bags of oxyTOCIN 30 Units/500 mL because the product did not contain the active drug.

    Product
    oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2340-2020·2020-06-17

    RayStation 5 Service Pack 3 Radiation Therapy Software Recalled

    RaySearch Laboratories is recalling RayStation 5 Service Pack 3 software due to a dose calculation error that may underestimate radiation dose.

    Product
    RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2279-2020·2020-06-17

    Genicon Natura Trocar Recall Due to Potential Tip Detachment

    Genicon, Inc. is recalling Natura Model 210-005-052 trocars because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • SevereNHTSA·20V359000·2020-06-17

    Volkswagen Recalls 2020 Jetta for Loose Front Brake Caliper Bolts

    Volkswagen is recalling one 2020 Jetta because front brake caliper bolts may come loose, potentially affecting brake performance and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2277-2020·2020-06-17

    Genicon Natura Cannula Recalled for Potential Optical Tip Detachment

    Genicon, Inc. is recalling Natura Model 210-105-251 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2273-2020·2020-06-17

    Genicon Natura Cannula Recall Due to Detachable Optical Tip

    Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2334-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 713
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2289-2020·2020-06-17

    Elekta Unity Radiation Therapy System Recalled for Legionella Risk

    Elekta, Inc. is recalling 32 Unity image-guided radiation therapy systems due to a potential risk of Legionella presence in the machine room heat exchanger condensation collection tray.

    Product
    Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2020·2020-06-17

    Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2327-2020·2020-06-17

    Canon Medical System Recalls Infinix-8000F Fluoroscopy Systems Due to Loose Bolts

    Canon Medical System is recalling 15 Infinix-8000F digital radiography systems because loose bolts may cause the catheterization table to tilt.

    Product
    Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2020·2020-06-17

    Genicon GENILook Cannula Recalled for Potential Tip Detachment

    Genicon, Inc. is recalling GENILook cannulas because the plastic optical tip may detach from the metal shaft. The recall affects 378 boxes distributed in the US and abroad.

    Product
    Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2353-2020·2020-06-17

    RayStation 7 Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 7 software due to errors in dose calculation algorithms that may underestimate radiation dose.

    Product
    RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2020·2020-06-17

    RayStation 6 Service Pack 3 Radiation Therapy Software Recall

    RaySearch Laboratories is recalling RayStation 6 Service Pack 3 software due to a calculation error that could underestimate radiation dose.

    Product
    RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2020·2020-06-17

    Genicon GENILook Cannula Recalled Due to Detaching Optical Tip

    Genicon, Inc. is recalling GENILook Model 200-105-251 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2339-2020·2020-06-17

    RayStation Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.

    Product
    RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2020·2020-06-17

    Siemens Artis X-Ray Systems Recalled for Electrical Contact Issues

    Siemens is recalling 15 Artis X-ray systems in the US because a power distributor defect may cause electrical contact interruptions, leading to procedure termination.

    Product
    Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 1009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2020·2020-06-17

    BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results

    BioFire Diagnostics is recalling FilmArray BCID Panels due to a risk of false positive Proteus results when used with specific blood culture media, which may lead to improper antibiotic treatment.

    Product
    FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Produ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60M
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2265-2020·2020-06-17

    ROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes

    ROi CPS LLC is recalling 40 custom procedure kits because they contain PosiFlush Syringes from a lot previously recalled by BD.

    Product
    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0982-2020·2020-06-17

    ConAgra Recalls Healthy Choice Pesto and Egg Bowls Due to Stone Risk

    ConAgra Foods is recalling Healthy Choice Pesto and Egg bowls because the farro ingredient may contain small stones.

    Product
    Healthy Choice Pesto and Egg bowls labeled in the following ways: 1) (for the US market) Healthy Choice Power Bowls Morning Pesto & Egg White Scramble, Net Wt. 7.2 OZ (204 g); UPC 0-72655-00083-4 2) (for the Canadian market) Healthy Choice, Power Bowls, All-Day Breakfast, Pesto
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-2285-2020·2020-06-17

    Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.

    Product
    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2020·2020-06-17

    HardyCHROM MRSA Recall for False Positive Results

    Hardy Diagnostics is recalling HardyCHROM MRSA kits because they may produce false positive results for methicillin-susceptible Staphylococcus aureus.

    Product
    HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2355-2020·2020-06-17

    Acuity Surgical Devices Recalls A Link Z Intervertebral Body Fusion Devices

    Acuity Surgical Devices is recalling A Link Z Intervertebral Body Fusion Devices due to a manufacturing issue that may prevent vertebral body bone screws from seating properly.

    Product
    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2020·2020-06-17

    RayStation 6 Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 6 software due to a calculation error that may underestimate radiation dose.

    Product
    RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2020·2020-06-17

    Genicon Natura Trocar Handle Recall Due to Detaching Optical Tip

    Genicon, Inc. is recalling Natura Model 210-005-152 trocar handles because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2267-2020·2020-06-17

    Genicon GENILook Medical Device Recalled Due to Detachment Risk

    Genicon, Inc. is recalling GENILook Model 200-005-152 medical devices because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-1306-2020·2020-06-17

    Pfizer Recalls Unasyn Injection Due to Particulate Matter

    Pfizer is recalling specific lots of Unasyn (ampicillin sodium and sulbactam sodium) for injection because particulate matter was identified after reconstitution.

    Product
    UNASYN — UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2020·2020-06-17

    Acuity A Link Z Spinal Fusion Device Recalled for Manufacturing Defect

    Acuity Surgical Devices is recalling 178 A Link Z intervertebral body fusion devices because a manufacturing issue prevented bone screws from seating properly.

    Product
    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0978-2020·2020-06-17

    Coastal Sunbelt Butternut Squash Recalled for Potential Listeria Contamination

    Coastal Sunbelt Produce Co. Inc. is recalling raw butternut squash due to potential Listeria monocytogenes contamination. The product was distributed in 11 states and Washington, D.C.

    Product
    Bin Butternut Squash, Bulk, Raw Product in Bins / 4, 5lb packages in each case
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2282-2020·2020-06-17

    Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2020·2020-06-17

    Elekta Unity Software Recall for Motion Monitoring Data Mismatch

    Elekta Limited is recalling specific Unity software versions due to a potential mismatch between contour data and motion monitoring images.

    Product
    Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2338-2020·2020-06-17

    Philips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption

    Philips Healthcare Informatics is recalling 26 units of IntelliSpace PACS 4.4 because images may potentially become corrupt while using the system.

    Product
    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2020·2020-06-17

    RayStation 8A Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8A software due to a defect in dose calculation algorithms that may underestimate radiation dose.

    Product
    RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2020·2020-06-17

    Genicon GENILook Cannula Recalled Due to Potential Tip Detachment

    Genicon, Inc. is recalling GENILook Model 200-105-151 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2336-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant co
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2262-2020·2020-06-17

    Ventana HE 600 Recalled for Electrical Short Risk

    Ventana Medical Systems is recalling 461 HE 600 instruments due to a cleaning solution leak that can cause electrical shorts and burned components.

    Product
    Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0983-2020·2020-06-17

    Wild Harvest Organic Fresh Basil Recalled for Cyclospora Contamination Risk

    UNFI General Corporate is recalling Wild Harvest Organic Fresh Basil due to potential contamination with Cyclospora cayetanensis. The product was distributed in Minnesota, South Dakota, and Wisconsin.

    Product
    Wild Harvest Organic Fresh Basil packaged in the following sized plastic containers: Net Wt 2 oz (57g), UPC 11535-50762, Net Wt 0.25 oz. (7g), UPC 11535-50450, Net Wt 0.75 oz. (21g), UPC 11535-50322, Net Wt. 4 oz. (113g), UPC 11535-50323. Distributed by Superval
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2274-2020·2020-06-17

    Genicon Natura Cannula Recall Due to Detachable Optical Tip

    Genicon, Inc. is recalling Natura Model 210-005-151 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-1290-2020·2020-06-17

    Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 4,224 bottles of Lisinopril 5 mg tablets because 10 mg tablets were found in the bottles.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·20140·2020-06-17

    Edwards Recalls Mechanical Heat Detectors Due to Fire Alert Failure

    Edwards Fire Safety is recalling about 85,000 mechanical heat detectors that may fail to activate during a fire, posing a risk of failure to alert consumers.

    Product
    Edwards Mechanical Heat Detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0984-2020·2020-06-17

    Adams Reserve Seafood Sauce Recalled for Undeclared Soy Lecithin

    Adams Extract & Spice LLC is recalling 1,389 units of Adams Reserve Sweet & Spicy Seafood Sauce due to undeclared soy lecithin. The product was distributed in Texas.

    Product
    Adams Reserve Sweet & Spicy Seafood Salmon NEY WT 2.5 OZ (73g) UPC code 4313 04950.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0976-2020·2020-06-17

    La Sonorense Flour Burrito Tortillas Recalled for Wheat Allergen Mislabeling

    La Sonorense, Inc. is recalling flour burrito tortillas sold in Arizona because the packaging did not properly list wheat as an allergen.

    Product
    La Sonorense Tortilla Factory, Flour Burrito Size, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0977-2020·2020-06-17

    La Sonorense Gorditas Recalled for Missing Wheat Allergen Labeling

    La Sonorense, Inc. is recalling 247 packs of Gorditas Sonora Style in Arizona due to missing wheat allergen labeling.

    Product
    La Sonorense Tortilla Factory, Gorditas Sonora Style, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2276-2020·2020-06-17

    Genicon Natura Cannula Recalled Due to Potential Tip Detachment

    Genicon, Inc. is recalling Natura Model 210-005-251 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2346-2020·2020-06-17

    RayStation 8B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 8B software due to errors in dose calculation algorithms that could underestimate radiation dose.

    Product
    RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2020·2020-06-17

    RayStation 9B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 9B Service Pack 1 due to a software error in dose calculation algorithms that could result in local underestimation of expected radiation dose.

    Product
    RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2020·2020-06-17

    BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results

    BioFire Diagnostics is recalling the FilmArray BCID Panel due to an increased risk of false positive Proteus results when used with specific blood culture media.

    Product
    FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Prod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2020·2020-06-17

    Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk

    Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2020·2020-06-17

    Siemens Atellica CH Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2020·2020-06-17

    RayStation 8B Service Pack 1 Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error that could underestimate radiation dose.

    Product
    RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 7133
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2269-2020·2020-06-17

    Genicon GENILook Cannula Recalled for Potential Tip Detachment

    Genicon, Inc. is recalling GENILook Model 200-005-251 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2268-2020·2020-06-17

    Genicon GENILook Laparoscopic Scope Recall Due to Detaching Optical Tip

    Genicon, Inc. is recalling GENILook Model 200-005-153 laparoscopic scopes because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2284-2020·2020-06-17

    Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2020·2020-06-17

    Biomet Recalls Comprehensive VRS Inserter Shoulder Prosthesis Devices

    Biomet is recalling 38 Comprehensive VRS Inserter shoulder prosthesis devices because the central screw drill may seize, potentially extending surgery time.

    Product
    Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2020·2020-06-17

    Genicon GENILook Medical Device Recalled for Potential Tip Detachment

    Genicon, Inc. is recalling GENILook Model 200-105-252 devices because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2350-2020·2020-06-17

    RayStation 9B Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.

    Product
    RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2020·2020-06-17

    Canon Medical System Recalls Infinix-8000V Catheterization Tables Due to Loose Bolts

    Canon Medical System is recalling 46 Infinix-8000V systems because loose bolts may cause the catheterization table to tilt.

    Product
    Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2020·2020-06-17

    Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure

    Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.

    Product
    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2331-2020·2020-06-17

    Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error

    Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2345-2020·2020-06-17

    RayStation 8A Software Recall for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8A Service Pack 1 software due to a dose calculation error that could underestimate radiation therapy doses.

    Product
    RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2020·2020-06-17

    Inari Medical Recalls Triever20 Aspiration Guide Catheter for Valve Failure

    Inari Medical is recalling 318 Triever20 Aspiration Guide Catheters because the hemostasis valve may fail to seal, causing loss of vacuum during thrombus aspiration.

    Product
    Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2328-2020·2020-06-17

    Intuitive Surgical Recalls 8mm Endoscope Sterilization Trays Due to Sterility Risk

    Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2020·2020-06-17

    Genicon GENILook Medical Device Recalled Due to Detached Optical Tip Risk

    Genicon, Inc. is recalling GENILook Model 200-105-152 devices because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2352-2020·2020-06-17

    RayStation 6 Service Pack 1 Radiation Therapy Software Recall

    RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software due to a calculation error that may underestimate radiation dose.

    Product
    RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2287-2020·2020-06-17

    Alcon Recalls AcrySof IQ Intraocular Lenses Due to Incorrect Diopter

    Alcon Research LLC is recalling 84 units of AcrySof IQ intraocular lenses because they have an incorrect diopter. The lenses were distributed nationwide.

    Product
    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2304-2020·2020-06-17

    Biomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files

    Biomet is recalling 8.0 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

    Product
    Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2281-2020·2020-06-17

    Siemens Atellica CH Fructosamine Reagent Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine Reagent because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding tw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling 16 units of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2293-2020·2020-06-17

    Eizo RadiForce GX560 Monochrome LCD Monitor Recalled for Display Defect

    Eizo Corporation is recalling 96 RadiForce GX560 monochrome LCD monitors because a marble pattern may infrequently appear on the screen under certain conditions.

    Product
    RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practiti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2356-2020·2020-06-17

    BD FACS Sample Prep Assistant II Recalled for Probe Wear Issues

    Becton, Dickinson and Company is recalling 95 units of the BD FACS Sample Prep Assistant II because probes may wear prematurely, causing sample dispensing failures.

    Product
    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2020·2020-06-17

    Immuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination

    Immuno-Mycologics is recalling 155 vials of Histoplasma ID Antigen because potential reagent contamination may cause false positive test results.

    Product
    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2357-2020·2020-06-17

    BD FACS Sample Prep Assistant II Upgrade Recalled for Probe Wear

    Becton, Dickinson and Company is recalling 51 units of the BD FACS Sample Prep Assistant II Upgrade due to premature probe wear that may cause sample dispensing issues.

    Product
    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2322-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling specific lots of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2020·2020-06-17

    Physio-Control Recalls Infant Child Starter Kits Due to Packaging Seal Issues

    Physio-Control is recalling 6,732 Infant Child Starter Kits because the packaging for the reduced energy electrodes was not properly sealed.

    Product
    Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2020·2020-06-17

    Biomet Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2294-2020·2020-06-17

    Eizo RadiForce RX360 Medical Monitor Recalled for Display Defect

    Eizo Corporation is recalling 1,466 RadiForce RX360 medical monitors because a marble pattern may infrequently appear on the display under certain conditions.

    Product
    RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Locking Pegs Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Pegs 60mm because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2337-2020·2020-06-17

    Philips SureSigns VM1 Monitor Recalled Due to Unverified Manufacturing Records

    Philips is recalling a specific SureSigns VM1 patient monitor because it was not intended for commercial distribution and lacks manufacturing records.

    Product
    Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2310-2020·2020-06-17

    Biomet A.L.P.S. T15 Multi-Directional Locking Screw Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. T15 Multi-Directional Locking Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2020·2020-06-17

    Ormco Damon Q2 Orthodontic Bracket Recalled for Packaging Labeling Error

    Ormco/Sybronendo is recalling 2,189 units of Damon Q2 Orthodontic Metal Brackets because the bracket torque was mislabeled on the packaging.

    Product
    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has bee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2020·2020-06-17

    Physio-Control Recalls Infant Defibrillation Electrodes Due to Packaging Seal Issues

    Physio-Control is recalling infant and child defibrillation electrodes because the packaging was not properly sealed. The recall affects units manufactured between August 2017 and October 2019.

    Product
    Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2292-2020·2020-06-17

    Olympus ENF-GP2 Fiberscope Recalled for Missing O Ring

    Olympus is recalling 19 ENF-GP2 Rhino-Laryngo Fiberscopes because they may be missing an O ring after being repaired with an incorrect service manual.

    Product
    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2020·2020-06-17

    Biomet A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve Recalled

    Biomet is recalling A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Design History Deficiencies

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because it was distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2280-2020·2020-06-17

    Siemens ADVIA Chemistry Fructosamine Reagent Recalled for Potential Interference

    Siemens is recalling ADVIA Chemistry Fructosamine Reagent because acetaminophen metabolites may interfere with test results, potentially affecting diabetic patient monitoring.

    Product
    ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients
    Category
    Medical Device
    Distribution
    Distributed nationwide

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